Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01172067
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2010-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
QuickOpt Chronic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058406', 'term': 'Cardiac Resynchronization Therapy'}], 'ancestors': [{'id': 'D002304', 'term': 'Cardiac Pacing, Artificial'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clay.cohorn@abbott.com', 'phone': '+1 972 309 8087', 'title': 'Clay Cohorn, Program Director', 'organization': 'CRT, Global Clinical Affairs, Cardiac Arrhythmias and Heart Failure, Abbott Medical Devices'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Quickopt Group', 'description': 'the QuickOpt Group patients will be optimized by QuickOpt(IEGM);\n\nCardiac Resynchronization Therapy: Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 6, 'seriousNumAtRisk': 198, 'deathsNumAffected': 23, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Echocardiography Group', 'description': 'the Echo Group patients will be optimized by Echo.\n\nOptimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography', 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 6, 'seriousNumAtRisk': 194, 'deathsNumAffected': 15, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Phrenic nerve stimulation', 'notes': 'Patient experience phrenic nerve stimulation. The event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated left ventricular pacing threshold', 'notes': 'Left ventricular pacing threshold increased.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary sinus dissection', 'notes': 'Patient sustained coronary sinus dissection; the event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right ventricular lead dislocation/displacement', 'notes': 'Right ventricular lead dislocation/displacement; the event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right atrial lead dislocation/displacement', 'notes': 'Right atrial lead dislocation/displacement; the event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular lead dislocation/displacement', 'notes': 'Left ventricular lead dislocation/displacement; the event is related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated pacing threshold of left ventricular lead; lead dislocation/displacem', 'notes': 'Elevated pacing threshold of left ventricular lead; lead dislocation/displacem; the event is related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection at pacing system', 'notes': 'Patient sustain infection at pacing system; the event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic shock', 'notes': 'Patient experienced anaphylactic shock; the event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Death; not related to study devices', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hopitalization', 'notes': 'Patient hopitalized then expired; death not related to study devices', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure Deterioration; Death', 'notes': 'Heart failure deteriorated; patient expired; SAE not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiopulmonary arrest, death', 'notes': 'Patient sustained cardiopulmonary arrest. Patient expired. The death is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Junctional rhythm, hypotension', 'notes': 'Patient sustained junctional rhythm and low blood pressure. The event was considered related to study device. The pace maker was re-interrogated.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure deterioration, hospitalization', 'notes': 'Heart failure deteriorated. Patient hospitalized. The event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure deterioration, elevated left ventricular pacing threshold', 'notes': 'Heart failure deteriorated. Left ventricular pacing threshold increased. The event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure deterioration, myocardial infarction, venous thrombosis, death', 'notes': 'Heart failure deteriorated. Patient sustained myocardial infarction and venous thrombosis. Patient expired. The death is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure deterioration, phrenic nerve stimulation', 'notes': 'Heart failure deteriorated. Patient experienced phrenic nerve stimulation. The event was considered related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial ischemia, staged heart bypass surgery', 'notes': 'Patient was diagnosed with myocardial ischemia and underwent staged heart bypass surgery. The event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest distress, short breaths', 'notes': 'Patient stated chest distress and short breaths. Patient was hospitalized. The event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral hemorrhage, death', 'notes': 'Patient sustained cerebral hemorrhage. Patient expired. The death is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematoma, low right atrial lead sensing', 'notes': 'Patient sustained haematoma; the right atrial lead sensing decreased. The event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pacemaker pocket ulceration', 'notes': 'Pacemaker pocket skin ulceration. The event is not related to study devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pacemaker reject', 'notes': "Patient's body rejected pacemaker. The event is not related to study devices.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QuickOpt Group', 'description': 'Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.'}, {'id': 'OG001', 'title': 'Echocardiography Group', 'description': 'Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.69', 'spread': '33.86', 'groupId': 'OG000'}, {'value': '-25.13', 'spread': '36.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and12 months', 'description': 'The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.', 'unitOfMeasure': 'Percent change in LVESV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 108 patients in the QuickOpt group and 118 patients in the Echocardiography group had LVESV measurements at both baseline and 12 months to allow comparison of the percent change in LVESV.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quickopt Group', 'description': 'the QuickOpt Group patients will be optimized by QuickOpt(IEGM);\n\nCardiac Resynchronization Therapy: Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.'}, {'id': 'FG001', 'title': 'Echocardiography Group', 'description': 'the Echo Group patients will be optimized by Echo.\n\nOptimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '37'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'QuickOpt Group', 'description': 'Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.'}, {'id': 'BG001', 'title': 'Echocardiography Group', 'description': 'Optimization using echocardiography: Optimization of the AV/PV and VV delays using echocardiography'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.38', 'spread': '11.77', 'groupId': 'BG000'}, {'value': '59.21', 'spread': '11.36', 'groupId': 'BG001'}, {'value': '60.17', 'spread': '11.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2010-07-28', 'resultsFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2010-07-28', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-04', 'studyFirstPostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline', 'timeFrame': 'Baseline and12 months', 'description': 'The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CRT', 'heart failure', 'optimization', 'Timing cycle optimization methods'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the CRTP/D patients with different optimization at 12 months after implantation.The hypothesis is that the Heart Remolding parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after implant is not inferior (10%) to the patients by Echo optimization。", 'detailedDescription': 'Clinical studies have demonstrated that the AVTI from QuickOptTM related significantly to the max aorta VTI (AVTI) by Echo, the concordance correlation coefficient (CCC) was so high from 0.96 to 0.99.\n\nBut up to now, there are no clinical trials to evaluate mid-long term clinical outcome for CRTP/D patients by QuickOptTM and Echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system\n\n * Patient is able to provide written informed consent for study participation\n\nExclusion Criteria:\n\n* • Patient has limited intrinsic atrial activity (≤ 40 bpm)\n\n * Patient has persistent or permanent AF\n * Patient has a 2o or 3o heart block\n * Patient's life expectancy is \\<12 months\n * Patient is \\<18 years old\n * Patient is pregnant\n * Patient is on IV inotropic agents\n * Patients who are ongoing other devices or agents study\n * Patients with heart transplanted or waiting for heart transplant\n * Patients with Hypertrophic and obstructive cardiomyopathy\n * Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement"}, 'identificationModule': {'nctId': 'NCT01172067', 'briefTitle': 'QuickOpt Chronic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Clinical Impact of Cardiac Resynchronization Therapy on Heart Failure Patients With QuickOpt and Echo Optimization', 'orgStudyIdInfo': {'id': 'CR-09-063-AP-HF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quickopt Group', 'description': 'the QuickOpt Group patients will be optimized by QuickOpt(IEGM);', 'interventionNames': ['Device: Cardiac Resynchronization Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Echocardiography group', 'description': 'the Echo Group patients will be optimized by Echo.', 'interventionNames': ['Device: Optimization using echocardiography']}], 'interventions': [{'name': 'Cardiac Resynchronization Therapy', 'type': 'DEVICE', 'description': 'Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.', 'armGroupLabels': ['Quickopt Group']}, {'name': 'Optimization using echocardiography', 'type': 'DEVICE', 'description': 'Optimization of the AV/PV and VV delays using echocardiography', 'armGroupLabels': ['Echocardiography group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}