Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-28 @ 8:10 AM
Study NCT ID:
NCT05855135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2023-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Combined CCM and ICD Device in HFrEF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, prospective, multicenter study of 300 subjects that will establish that the device can appropriately sense and convert episodes of induced VF "on the table" in the implant procedure room, spontaneous episodes of VT/VF that occur during the study follow-up period, and ensure that the inappropriate shock rate is not unacceptably high.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inappropriate Shock Rate out to 2-years', 'timeFrame': 'Implant to 2 years', 'description': 'Evaluate the device effectiveness in converting spontaneous VT/VF through the time when the last subject enrolled completes the 6-month visit. Each subject will be followed for 2-years after implant to capture additional spontaneous episodes that may occur.'}, {'measure': 'Charging non-compliance', 'timeFrame': 'Implant to 2 years', 'description': 'Evaluate subject charging non-compliance defined as \\>14 days between interval charging sessions, overall and frequency of non-compliance in the same subject.'}, {'measure': 'Longitudinal levels of activity', 'timeFrame': 'Implant to 2 years', 'description': 'Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends.'}, {'measure': 'Battery degradation and longevity', 'timeFrame': 'Implant to 2 years', 'description': 'Assess battery degradation and longevity either remotely or during an in-person follow-up at 2 years (+/- 60 days) by recording QHR battery voltage as measured by the Integra CCM-D IPG. The measurement under nominal conditions is expected to be 2.85V or higher, consistent with a 20-year device longevity.'}, {'measure': 'Compare worsening heart failure events pre- and post-implant', 'timeFrame': '12 months prior to implant and 12 months post-implant', 'description': 'Track unscheduled cardiovascular-related healthcare encounters from 12 months prior to implant, if available, to 12 months post-implant'}, {'measure': 'All-cause mortality', 'timeFrame': '1 and 2 years post-implant', 'description': 'Assess all-cause mortality using Seattle Heart Failure Model (SHFM) and comorbidity burden as a predictive comparator at 1 year and 2 years post-implant'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'Baseline to 6-months', 'description': "Compare change in subject's perception of their heart failure symptoms, as measured by KCCQ, from baseline to 6 months."}, {'measure': 'EQ-5D-5L', 'timeFrame': 'Baseline to 6-months', 'description': "Compare change in subject's perception of their health status, as measured by the EQ-5D-5L, from baseline to 6 months."}, {'measure': 'Six Minute Walk Distance (6MWD)', 'timeFrame': 'Baseline to 6 months', 'description': 'Compare change in functional capacity, as measured by 6MWD, from baseline to 6 months.'}], 'primaryOutcomes': [{'measure': 'Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)', 'timeFrame': 'Implant', 'description': 'Evaluate the device effectiveness in converting induced VF at the time of implantation.'}, {'measure': 'Device-related Complications (Primary Safety Objective)', 'timeFrame': 'Implant to 6 months', 'description': 'Evaluate device-related complications through 6-months (excluding lead-related complications).'}], 'secondaryOutcomes': [{'measure': 'Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)', 'timeFrame': 'Implant to 6 months', 'description': 'Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'HFrEF', 'Stage C Heart Failure', 'Stage D Heart Failure', 'Defibrillation Efficacy Testing', 'Induced Ventricular Fibrillation', 'Ventricular fibrillation', 'Ventricular tachycardia', 'Implantable cardioverter defibrillator', 'Sudden cardiac arrest'], 'conditions': ['Heart Failure', 'Heart Failure With Reduced Ejection Fraction', 'Implantable Defibrillator User', 'CCM Therapy', 'Non-ischemic Cardiomyopathy', 'Ischemic Cardiomyopathy', 'Sudden Cardiac Arrest', 'Arrhythmias, Cardiac', 'Ventricular Tachycardia', 'Ventricular Fibrillation']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).\n\nEligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals must meet all the following:\n\n1. Patient is aged 18 years or older;\n2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;\n3. Patient has HFrEF (LVEF ≤40%);\n4. Patient is on GDMT for heart failure;\n5. Patient has a Class I or Class II indication for an ICD\n6. Patient has a reasonable expectation of meaningful survival of \\> 1 year;\n7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;\n8. Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;\n2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;\n3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;\n4. Prior heart transplant or ventricular assist device;\n5. Implanted mechanical tricuspid valve;\n6. PR interval greater than 375ms or advanced AV block;\n7. In situ S-ICD, pacemaker, or CRT device;\n8. Indicated for CRT;\n9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);\n10. Indicated for permanent bradyarrhythmia pacing;\n11. Unstable angina pectoris within 30 days prior to study consent;\n12. Pregnant or planning to become pregnant during the study;\n13. Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.\n14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.'}, 'identificationModule': {'nctId': 'NCT05855135', 'acronym': 'INTEGRA-D', 'briefTitle': 'Assessment of Combined CCM and ICD Device in HFrEF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Impulse Dynamics'}, 'officialTitle': 'Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects With Heart Failure and Reduced Ejection Fraction', 'orgStudyIdInfo': {'id': 'RG_PRO_345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CCM-D Implant', 'description': 'The subject is implanted with the CCM-D device.', 'interventionNames': ['Device: OPTIMIZER® Integra CCM-D System (Treatment Arm)']}], 'interventions': [{'name': 'OPTIMIZER® Integra CCM-D System (Treatment Arm)', 'type': 'DEVICE', 'description': 'The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a "Cardiac Contractility Modulation - Defibrillator". All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years.', 'armGroupLabels': ['CCM-D Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Heart', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'CardioVascular Associates of Mesa', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85208', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Cardiovascular Associates', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Rhythm', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CVC Cardiovascular Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85306', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Heart', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Honor Health', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Denver Cardiology Associates', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford HealthCare', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward Health Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center Miami Beach', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Weston', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66103', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63106', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis VA', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63136', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Heart and Vascular', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart and Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '08034', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '08035', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Heart House - Cardiovascular Associates of the Delaware Valley', 'geoPoint': {'lat': 39.87734, 'lon': -75.06462}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center / NewYork-Presbyterian', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Sanger Heart and Vascular Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'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': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'St. Francis Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland VA Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Luke's Bethlehem", 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bryn Mawr Medical Specialists Association', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '17602', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster General Hospital', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Presbyterian', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Stern Cardiovascular Foundation', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Research Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical City Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical City Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston VA Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Christus Trinity Clinic', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Centra Health', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Chippenham Hospital', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle VA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Niraj Varma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Nir Uriel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Impulse Dynamics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}