9 completed, 1 active not recruiting, 1 recruiting. 11 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 11 | Completed 9, Active not recruiting 1, 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 |
|---|---|---|---|---|---|---|
| Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study Atala™ lead and EV-ICD Pulse Generator - Ventricular Arrythmia, Ventricular Fibrillation | Not applicable | Recruiting | AtaCor Medical, Inc. | 280 | 2026-07-02 | 2026-10-09 |
| Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study Atala™ lead - Ventricular Arrythmia, Ventricular Fibrillation | Not applicable | Active not recruiting | AtaCor Medical, Inc. | 19 | 2025-02-25 | 2025-12-04 |
| Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study AtaCor StealthTrac Lead - Conduction Defect | Not applicable | Completed | AtaCor Medical, Inc. | 12 | 2023-09-19 | 2025-08-24 |
| Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study AtaCor EV-ICD Lead - Ventricular Arrythmia, Ventricular Tachycardia | Not applicable | Completed | AtaCor Medical, Inc. | 21 | 2023-09-05 | 2024-04-03 |
| Subcostal Temporary Extravascular Pacing V Study AtaCor StealthTrac Lead - Conduction Defect | Not applicable | Completed | AtaCor Medical, Inc. | 29 | 2023-01-23 | 2025-08-24 |
| Subcostal Temporary Extravascular Pacing IV (STEP IV) Study AtaCor StealthTrac Lead - Conduction Defect | Not applicable | Completed | AtaCor Medical, Inc. | 12 | 2022-08-17 | 2023-03-03 |
| Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study AtaCor EV-ICD Lead - Ventricular Arrhythmia, Ventricular Tachycardia | Not applicable | Completed | AtaCor Medical, Inc. | 18 | 2022-05-18 | 2023-08-29 |
| Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study AtaCor EV-ICD Lead - Ventricular Arrhythmia, Ventricular Tachycardia | Not applicable | Completed | AtaCor Medical, Inc. | 18 | 2021-11-17 | 2022-07-08 |
| AtaCor Subcostal Temporary Extravascular Pacing III Study AtaCor StealthTrac Lead - Conduction Defect | Not applicable | Completed | AtaCor Medical, Inc. | 33 | 2020-10-03 | 2022-07-07 |
| Subcostal Temporary Extracardiac Pacing II Study StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid, Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing) - Conduction Defect | Not applicable | Completed | AtaCor Medical, Inc. | 7 | 2020-07-28 | 2021-06-11 |
| Subcostal Temporary Extracardiac Pacing Study Subcostal Temporary Extracardiac Pacing Lead - Conduction Defect | Not applicable | Completed | AtaCor Medical, Inc. | 12 | 2019-08-25 | 2021-02-03 |
Arrhythmias, Cardiac (6) · Tachycardia, Ventricular (5) · Ventricular Fibrillation (5)
Negative-Pressure Wound Therapy (1)
Paraguay (9) · New Zealand (3) · Croatia (2) · Czechia (1) · Netherlands (1) · United States (1)
Martin C Burke, DO (7) · Adrian Ebner, M.D. (2) · Martin Burke, D.O. (2)