4 completed, 2 recruiting, 2 terminated, 1 active not recruiting. 9 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 9 | Completed 4, Recruiting 2, Terminated 2, Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Assessment of Combined CCM and ICD Device in HFrEF OPTIMIZER® Integra CCM-D System (Treatment Arm) - Heart Failure, Heart Failure With Reduced Ejection Fraction | Not applicable | Active not recruiting | Impulse Dynamics | 300 | 2023-05-17 | 2026-11-06 |
| Cardiac Contractility Modulation in Chagas Heart Disease Cardiac Contractility Modulation (CCM), CRT - Chagas Cardiomyopathy, Heart Failure | Not applicable | Recruiting | InCor Heart Institute | 60 | 2022-05-25 | 2026-07-08 |
| Assessment of CCM in HF With Higher Ejection Fraction Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System, OPTIMIZER™ Smart Mini System - Heart Failure, Heart Failure With Preserved Ejection Fraction | Not applicable | Recruiting | Impulse Dynamics | 1500 | 2022-02-03 | 2026-10-23 |
| CCM in Heart Failure With Preserved Ejection Fraction Optimizer SMART - Heart Failure, Diastolic | Not applicable | Completed | Impulse Dynamics | 47 | 2018-05-01 | 2024-04-23 |
| Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System Optimizer Smart System with 2-leads - Heart Failure, Congestive Heart Failure | Not applicable | Completed | Impulse Dynamics | 60 | 2017-10-23 | 2020-01-14 |
| Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System Optimizer Smart System - Heart Failure, Congestive Heart Failure | Not applicable | Terminated | Impulse Dynamics | 106 | 2017-07-01 | 2021-11-23 |
| Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure OPTIMIZER, Optimal medical therapy - Heart Failure | Not applicable | Terminated | Impulse Dynamics | 50 | 2014-02-01 | 2020-09-02 |
| Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C Optimizer System, No intervention: Optimal medical therapy - NYHA Class III Heart Failure, NYHA Class IV Heart Failure | Not applicable | Completed | Impulse Dynamics | 160 | 2011-01-01 | 2021-09-17 |
| Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5 OPTIMIZER System - Heart Failure, Congestive | Not applicable | Completed | Impulse Dynamics | 428 | 2005-02-01 | 2020-08-06 |
Heart Failure (8) · Heart Failure, Diastolic (2) · Arrhythmias, Cardiac (1) · Bundle-Branch Block (1) · Chagas Cardiomyopathy (1) · Death, Sudden, Cardiac (1) · Tachycardia, Ventricular (1) · Ventricular Fibrillation (1)
Angiotensin Receptor Antagonists (1) · Mineralocorticoid Receptor Antagonists (1)
United States (6) · Germany (4) · Czechia (2) · Poland (2) · Sweden (2) · Australia (1) · Austria (1) · Brazil (1) · Italy (1) · Portugal (1) · Spain (1)
Daniel Burkhoff, MD, PhD (2) · Carsten Tschoepe, Prof. (1) · Dan Burkhoff, M.D, Ph.D. (1) · David D. Gutterman, MD (1) · Gerhard Hindricks, Prof. (1) · Javed Butler, MD, MPH, MBA (1) · Nir Uriel, MD (1) · Niraj Varma, MD, PhD (1) · Oussama Wazni, MD, MBA (1)
PMID 10677747, PMID 10707756, PMID 11175486, PMID 15845889, PMID 16202650, PMID 16928995, PMID 17339569, PMID 17891282, PMID 18545843, PMID 18926146, PMID 19131444, PMID 19142374, PMID 19168514, PMID 19753454, PMID 20399979, PMID 23621145, PMID 2365530, PMID 2486527, PMID 27394714, PMID 29754812, PMID 31772622, PMID 32264716, PMID 35855646, PMID 37980262, PMID 3997291, PMID 4982469, PMID 4994717, PMID 7055867, PMID 7547025, PMID 7987526, PMID 7994859, PMID 8175216, PMID 8187110, PMID 8650479, PMID 8728813, PMID 8904674