Trials / Completed
CompletedNCT02268942
HW006 LATERAL Thoracotomy
A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
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 are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HeartWare HVAD | Implant of HeartWare HVAD via thoracotomy implant technique |
| PROCEDURE | Thoracotomy | Thoracotomy implant technique |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-10-01
- Completion
- 2018-10-01
- First posted
- 2014-10-20
- Last updated
- 2019-12-02
- Results posted
- 2019-11-12
Locations
26 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02268942. Inclusion in this directory is not an endorsement.