Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-03 @ 8:24 AM
Study NCT ID:
NCT04798768
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2021-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Julie.West@bsci.com', 'phone': '651-582-4721', 'title': 'Julie West', 'organization': 'Boston Scientific'}, 'certainAgreement': {'otherDetails': 'PI shall submit publication to Sponsor for review at least 60 days prior to submission. Sponsor reserves the right to delete any confidential info or other proprietary info of Sponsor (not incl. Results). Sponsor may extend 90 days to protect its intellectual property (IP) interests. PI shall be free to publish the results of the study after: Initial Publication is published; notification by Sponsor that Initial Publication is no longer planned; or 12 mo. after the expiration date at all sites', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study is limited by the nonrandomized design with no comparator group. Prespecified goals for safety and performance were used to define endpoints. Patients were selected with a high risk of ventricular tachycardia. The findings may not be generalizable to other patients who require S-ICDs or who have S-ICDs already implanted.'}}, 'adverseEventsModule': {'timeFrame': 'Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)', 'description': 'Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).', 'eventGroups': [{'id': 'EG000', 'title': 'MODULAR ATP Study Participants', 'description': 'All-cause mortality evaluated in all enrolled participants (N=297). Adverse events were evaluated for participants implanted or attempted with the mCRM Therapy System (S-ICD after study enrollment, and/ or the EMPOWER LP), N=288. Individual adverse event categories evaluated in participants at risk for that event category (287 Leadless Cardiac Pacemaker, 9 TV Lead Extraction Procedure, 288 remaining adverse event categories).', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 297, 'otherNumAffected': 86, 'seriousNumAtRisk': 288, 'deathsNumAffected': 18, 'seriousNumAffected': 113}], 'otherEvents': [{'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Cardiac Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD System Patient Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and Infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leadless Cardiac Pacemaker - Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leadless Cardiac Pacemaker - Right Ventricle - Brady', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD Defibrillation and Conversion Testing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD System Patient Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD System Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and Connective Tissue Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Modular System (LCP+S-ICD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD Electrode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD PG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD System Therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and Lymphatic System Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 86, 'numAffected': 54}], 'organSystem': 'Cardiac Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Endocrine Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'General Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Infections and Infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leadless Cardiac Pacemaker - Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD Defibrillation and Conversion Testing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD System Patient Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD System Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'TV Lead Extraction Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Injury, Poisoning and Procedural Complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous System Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leadless Cardiac Pacemaker - Right Ventricle - Brady', 'stats': [{'groupId': 'EG000', 'numAtRisk': 287, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Modular System (LCP+S-ICD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD Electrode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD PG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD System Diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'S-ICD System Therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Renal and Urinary Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, Thoracic and Mediastinal Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and Subcutaneous Tissue Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Vascular Disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interim Analysis Cohort', 'description': 'This subject cohort was determined by the point in time at which 134 subjects (pre-specified in the endpoint design) had a 6 Month Visit with data submitted in the database. Once the 134th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the identified implant date is included, even if their 6-month follow-up was after the identified subject. This resulted in 162 subjects to be included in the Interim Analysis Cohort.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.5', 'comment': 'One-sided test was performed with 1.2% alpha. Lower one-sided 98.8% confidence limit was compared to performance goal of 86%. It was pre-specified to only calculate the lower confidence interval.', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implant through 6 Months Post-Implant', 'description': 'Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant', 'unitOfMeasure': '% of subjects free from complication', 'dispersionType': '98.8% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CE Mark Cohort', 'description': 'This subject cohort was determined by the point in time at which 112 subjects had a 12 Month Visit with data submitted in the database. Once the 112th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the determined implant date is included, even if their 12 Month Visit occurred after subject the identified subject. This resulted in 117 subjects to be included in the CE Mark Analysis Cohort.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'comment': 'One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 81%. It was pre-specified to only calculate the lower confidence interval.', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implant through 12 Months Post-Implant', 'description': 'Major EMPOWER MPS System- and Procedure-related Complication-free Rate\n\nSubjects will be assessed for safety issues related to the procedure or system through 12 months post implant', 'unitOfMeasure': '% of subjects free from complication', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Postures', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interim Analysis Cohort', 'description': 'This subject cohort was determined by the point in time at which 134 subjects (pre-specified in the endpoint design) had a 6 Month Visit with data submitted in the database. Once the 134th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the identified implant date is included, even if their 6-month follow-up was after the identified subject. This resulted in 162 subjects to be included in the Interim Analysis Cohort.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.8', 'comment': 'One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 88%. It was pre-specified to only calculate the lower confidence interval.', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the 6 Month Follow-up', 'description': 'Communication Success between the S-ICD and EMPOWER PG\n\nData from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.', 'unitOfMeasure': 'Adjusted % with successful communication', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Postures', 'denomUnitsSelected': 'Postures', 'populationDescription': 'Number of subjects in the interim analysis cohort who underwent S-ICD to EMPOWER LP communication testing at 6 months in at least one of four postures. Results were adjusted using a repeated measures logistic regression model'}, {'type': 'PRIMARY', 'title': 'Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interim Analysis Cohort', 'description': 'This subject cohort was determined by the point in time at which 134 subjects (pre-specified in the endpoint design) had a 6 Month Visit with data submitted in the database. Once the 134th subject that fulfilled that requirement was identified, their EMPOWER LP implant date was used to determine the cohort. Any subject with an EMPOWER LP implant or attempted EMPOWER LP implant on or before the identified implant date is included, even if their 6-month follow-up was after the identified subject. This resulted in 162 subjects to be included in the Interim Analysis Cohort.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.4', 'comment': 'One-sided test was performed with 2.5% alpha. Lower one-sided 97.5% confidence limit was compared to performance goal of 80%. It was pre-specified to only calculate the lower confidence interval.', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the 6 Month Follow-up', 'description': 'Proportion of Subjects with Adequate Pacing Capture Threshold\n\nEffectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width', 'unitOfMeasure': '% of subjects with PCT <= 2V @ 0.4 ms', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects in the interim analysis cohort with Pacing Capture Threshold data at 6 months'}, {'type': 'SECONDARY', 'title': "Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients implanted with S-ICD and leadless cardiac pacemaker', 'description': 'Patients implanted with an S-ICD and leadless cardiac pacemaker that complete intended testing based on the study protocol\n\nmCRM Therapy System: Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '1.02'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the 3 Month Visit', 'description': "Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model\n\nUsing the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test", 'unitOfMeasure': 'Beta coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this endpoint were obtained from the subset of subjects who consented into the substudy and performed treadmill testing at 3 months'}, {'type': 'SECONDARY', 'title': 'Secondary Safety Endpoint', 'timeFrame': 'Implant through 2 years post-implant', 'description': 'All-Cause Survival; data not reported as it is still being collected', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients implanted with S-ICD and leadless cardiac pacemaker', 'description': 'Patients implanted with an S-ICD and leadless cardiac pacemaker that complete intended testing based on the study protocol\n\nmCRM Therapy System: Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}]}, {'type': 'Implanted with mCRM Therapy System or Attempt or Partial Implant', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}]}, {'type': 'Implanted with mCRM Therapy System or Attempt', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}]}, {'type': 'Implanted with mCRM Therapy System', 'achievements': [{'groupId': 'FG000', 'numSubjects': '286'}]}, {'type': 'Interim Analysis Cohort', 'achievements': [{'comment': 'Pre-specified interim analysis for 6 month endpoints', 'groupId': 'FG000', 'numSubjects': '162'}]}, {'type': 'CE Mark Cohort', 'achievements': [{'comment': 'Pre-specified 12-month safety analysis for CE Mark submission', 'groupId': 'FG000', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'comment': 'Study is ongoing. As of the date of the snapshot, 264 subjects are actively being followed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MODULAR ATP Study Participants', 'description': 'Patients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'All subjects that signed the study informed consent were included', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '245', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Not disclosed', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '6.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LVEF', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '13.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NYHA Classification', 'classes': [{'categories': [{'title': 'Class I', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': 'Class II', 'measurements': [{'value': '146', 'groupId': 'BG000'}]}, {'title': 'Class III', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Class IV', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'NYHA Classification of severity of heart failure places subjects in 1 of 4 categories based on how much they are limited during physical activity, based on physician assessment.\n\nClass I = normal function status, Class II = Slight limitation of functional status, Class III = Marked limitation of functional status, Class IV = Severe limitation of functional status.', 'unitOfMeasure': 'Participants'}, {'title': 'Prevention status', 'classes': [{'categories': [{'title': 'Primary Prevention', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}, {'title': 'Secondary Prevention', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ischemic cardiomyopathy', 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-ischemic cardiomyopathy', 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Renal dysfunction', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hyperlipidemia', 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-29', 'size': 1730509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-06T10:46', 'hasProtocol': True}, {'date': '2025-05-22', 'size': 296155, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-22T15:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 297}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2021-03-08', 'resultsFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-06-23', 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months', 'timeFrame': 'Implant through 6 Months Post-Implant', 'description': 'Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant'}, {'measure': 'Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months', 'timeFrame': 'Implant through 12 Months Post-Implant', 'description': 'Major EMPOWER MPS System- and Procedure-related Complication-free Rate\n\nSubjects will be assessed for safety issues related to the procedure or system through 12 months post implant'}, {'measure': 'Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG', 'timeFrame': 'At the 6 Month Follow-up', 'description': 'Communication Success between the S-ICD and EMPOWER PG\n\nData from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.'}, {'measure': 'Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder', 'timeFrame': 'At the 6 Month Follow-up', 'description': 'Proportion of Subjects with Adequate Pacing Capture Threshold\n\nEffectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width'}], 'secondaryOutcomes': [{'measure': "Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test", 'timeFrame': 'At the 3 Month Visit', 'description': "Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model\n\nUsing the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test"}, {'measure': 'Secondary Safety Endpoint', 'timeFrame': 'Implant through 2 years post-implant', 'description': 'All-Cause Survival; data not reported as it is still being collected'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tachycardia, Ventricular', 'Arrhythmia, Ventricular']}, 'referencesModule': {'references': [{'pmid': '37520021', 'type': 'BACKGROUND', 'citation': 'Lloyd MS, Brisben AJ, Reddy VY, Blomstrom-Lundqvist C, Boersma LVA, Bongiorni MG, Burke MC, Cantillon DJ, Doshi R, Friedman PA, Gras D, Kutalek SP, Neuzil P, Roberts PR, Wright DJ, Appl U, West J, Carter N, Stein KM, Mont L, Knops RE. Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm O2. 2023 Jun 2;4(7):448-456. doi: 10.1016/j.hroo.2023.05.004. eCollection 2023 Jul.'}, {'pmid': '38767244', 'type': 'RESULT', 'citation': 'Knops RE, Lloyd MS, Roberts PR, Wright DJ, Boersma LVA, Doshi R, Friedman PA, Neuzil P, Blomstrom-Lundqvist C, Bongiorni MG, Burke MC, Gras D, Kutalek SP, Amin AK, Fu EY, Epstein LM, Tolosana JM, Callahan TD, Aasbo JD, Augostini R, Manyam H, Nair DG, Mondesert B, Su WW, Pepper C, Miller MA, Grammes J, Saleh K, Marquie C, Merchant FM, Cha YM, Cunnington C, Frankel DS, West J, Matznick E, Swackhamer B, Brisben AJ, Weinstock J, Stein KM, Reddy VY, Mont L; MODULAR ATP Investigators. A Modular Communicative Leadless Pacing-Defibrillator System. N Engl J Med. 2024 Oct 17;391(15):1402-1412. doi: 10.1056/NEJMoa2401807. Epub 2024 May 18.'}, {'pmid': '41231774', 'type': 'DERIVED', 'citation': 'Lloyd MS, Reddy VY, Roberts P, Doshi RN, Wright DL, Boersma LV, Friedman PA, Neuzil P, Blomstrom-Lundqvist C, Bongiorni MG, Burke MC, Gras D, Kutalek SP, Marijon E, Tolosana JM, Amin AK, Epstein LM, Aasbo JD, Callahan TD, Brisben A, West J, Matznick E, Speakman B, Bachman TN, Mont L, Knops RE. One-Year Outcomes of the MODULAR ATP Trial: A Novel Leadless Pacemaker in Wireless Communication With a Subcutaneous Implantable Cardioverter Defibrillator. Circ Arrhythm Electrophysiol. 2025 Nov 13:e014395. doi: 10.1161/CIRCEP.125.014395. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.', 'detailedDescription': 'The MODULAR ATP Clinical Study will enroll subjects with a standard Implantable Cardioverter Defibrillator (ICD) indication applying international practice guidelines, as well as those who already have an implanted S-ICD System and satisfy the inclusion criteria for this study, while not meeting any exclusion criteria. Subjects will be followed for at least 6 months following mCRM Therapy System implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient who meets Class I, IIa, or IIb guideline ICD indications\\[i\\],\\[ii\\], or who has an existing TV-ICD\\[iii\\] or S-ICD\\[iv\\]\n* Patient who is deemed to be at risk for MVT based on at least ONE of the following:\n\n * History of Non-Sustained MVT with LVEF ≤ 50%\n * History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant cardiac scar\\*\n * History of syncope deemed to be arrhythmic in origin\n * History of ischemic cardiomyopathy with LVEF ≤35%\n * History of non-ischemic cardiomyopathy with LVEF ≤35% and significant scar\\*\n* Patient who is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol\n* Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law\n\nExclusion Criteria:\n\n* Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant\n* Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed)\n* Patient with a known LA thrombus\n* Patient with a ventricular arrhythmia due to a reversible cause\n* Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT)\n* Patient with another implanted medical device that could interfere with implant of the leadless pacemaker, such as an implanted inferior vena cava filter or mechanical tricuspid heart valve\n* Patient requires rate-responsive pacing therapy\n* Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm)\n* Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days\n* Inability to access femoral vein with a 21-French or larger inner diameter introducer sheath due to known anatomy condition, recent surgery, and/ or other relevant condition\n* Patient who has an active implanted electronic medical device intended for chronic use concomitantly with the study system, such as a left ventricular assist device (LVAD). Note that a temporary pacing wire is allowed.\n* Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)\n* Patient with a known cardiovascular anatomy that precludes implant in the right ventricle\n* Patient with a known allergy to any system components\n* Patient with a known or suspected intolerance to S-ICD conversion testing, based on physician discretion\n* Patient is not likely to have meaningful survival\\*\\* for at least 12 months (documented or per investigator's discretion)\n* Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/ registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.\n* Patient who is a woman of childbearing potential who is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion)\n\n \\[i\\]Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391.\n\n\\[ii\\] 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart Journal (2015) 36, 2793-2867.\n\n\\[iii\\] TV-ICD system is expected to be fully explanted during or prior to full Coordinated System implant\n\n\\[iv\\] Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD Pulse Generator; Patients with an existing S-ICD PG subject to the electrical overstress field action are only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219, or future BSC S-ICD Pulse Generator\n\n\\*Significant cardiac scar is defined as a scar involving at least one ventricular myocardial segment (i.e., basal infero-septum) as identified in the official findings of a cMRI, or nuclear viability study, or echo report by the interpreting radiologist/ cardiologist who is not affiliated with the study\n\n\\*\\*meaningful survival means that a patient has a reasonable quality of life and functional status"}, 'identificationModule': {'nctId': 'NCT04798768', 'acronym': 'MODULAR ATP', 'briefTitle': 'Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing', 'orgStudyIdInfo': {'id': 'C1907'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MODULAR ATP Study Participants', 'description': 'All subjects that signed the informed consent were included.\n\nPatients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware.', 'interventionNames': ['Device: mCRM Therapy System']}], 'interventions': [{'name': 'mCRM Therapy System', 'type': 'DEVICE', 'otherNames': ['Communication of S-ICD to Leadless Cardiac Pacemaker (LCP)'], 'description': 'Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.', 'armGroupLabels': ['MODULAR ATP Study Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '84258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Healthcare - Shea', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arrhythmia Research Group', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Hospital - University Medical Center', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Health Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Erlanger Medical Center', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Kepler Universitaetsklinikum', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Quebec (Montreal Heart)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Na Homolce Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble - Hospital Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes-Hopital Laennec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hospital European Georges-Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Spedali Civil di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cotignola', 'country': 'Italy', 'facility': 'Maria Cecilia Hospital SPA', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'AZ Osp Monaldi', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'LS1 EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'The General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'L14 3PE', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool Heart and Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Heart Center', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton University Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Michael Lloyd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Reinoud Knops, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam University Medical Centre'}, {'name': 'Lluis Mont, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic, University of Barcelona'}, {'name': 'Vivek Reddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Mount Sinai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD with other researchers in this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}