Trials / Completed
CompletedNCT02170363
HeartMate 3™ CE Mark Clinical Investigation Plan
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol. This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Left Ventricular Assist System (LVAS) | Implantation of left ventricular assist device for hemodynamic support |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-05-01
- Completion
- 2020-03-09
- First posted
- 2014-06-23
- Last updated
- 2022-06-27
- Results posted
- 2018-02-15
Locations
10 sites across 6 countries: Australia, Austria, Canada, Czechia, Germany, Kazakhstan
Source: ClinicalTrials.gov record NCT02170363. Inclusion in this directory is not an endorsement.