3 completed, 2 unknown. 3 Not applicable, 2 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 3 | Unknown 2, Completed 1 |
| Phase 2 | 2 | Completed 2 |
| Phase 3 | 1 | Completed 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 |
|---|---|---|---|---|---|---|
| A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure Algisyl, Standard Medical Therapy - Heart Failure, Dilated Cardiomyopathy | Not applicable | Unknown | LoneStar Heart, Inc. | 240 | 2017-08-01 | 2017-03-17 |
| An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001 Algisyl-LVR - Heart Failure, Cardiomyopathy | Not applicable | Unknown | LoneStar Heart, Inc. | 24 | 2014-01-01 | 2014-08-27 |
| A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure Algisyl-LVR, Standard medical therapy - Heart Failure, Dilated Cardiomyopathy | Phase 2 / Phase 3 | Completed | LoneStar Heart, Inc. | 78 | 2012-08-01 | 2017-03-15 |
| Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery Algisyl-LVR - Dilated Cardiomyopathy | Phase 2 | Completed | LoneStar Heart, Inc. | 11 | 2009-02-01 | 2012-11-30 |
| A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG) Plexisyl-AF, No Treatment - Atrial Fibrillation | Not applicable | Completed | LoneStar Heart, Inc. | 32 | 2008-02-01 | 2011-03-10 |
Cardiomyopathy, Dilated (4) · Heart Failure (4) · Atrial Fibrillation (1) · Cardiomyopathies (1)
Drug Therapy (2) · Surgical Procedures, Operative (1)
Germany (3) · Italy (2) · Romania (2) · Australia (1) · Netherlands (1) · New Zealand (1) · Poland (1)
Ionel Droc, MD (1) · Klaus Matschke, MD (1) · Maurizio Volterani, MD (1) · Robert Bauernschmitt, MD (1)