Clinical trial
A Prospective, Single Arm, Multi-Center Clinical Study in Collaboration With the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS�) to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD� System in Patients With A
This is a prospective, multi-center,single arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD® System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) protocol and database.
All participating centers will be current INTERMACS® sites in good standing and will follow the INTERMACS® protocol and procedures.
Primary Outcome Measures:
- Success Definition [ Time Frame: Six Months ]
- Alive on the originally implanted device at 6 months, and the subject has not had a stroke with a Modified Ranking Scale Score ≥ 4 at the next scheduled follow-up that is > 3 months post stroke; or
- Transplanted by Month 6, or
- Explanted for recovery by Month 6.
| Category | Value |
|---|---|
| Date last updated at source | 2017-02-20 |
| Study type(s) | Interventional |
| Expected enrolment | 145 |
| Study start date | 2014-11-01 |
| Estimated primary completion date | 2021-04-01 |