NCT02268942

HW006 LATERAL Thoracotomy

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT02268942

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.

Eligibility

Inclusion Criteria:

1. Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry.
2. Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).
3. Subject signed an Intermacs® informed consent if required by local IRB policy.
4. Subject signed a HeartWare informed consent.

Exclusion Criteria:

1. Subject is incarcerated (prisoner).
2. Subject did not sign the informed consent at sites where waiver of consent was not granted.
3. Body Surface Area (BSA) < 1.2 m\^2.
4. Prior cardiac transplant or cardiomyoplasty.
5. Subject is receiving a BiVAD.
6. Subject is receiving the device as an RVAD.
7. Subject data is generated from non- Intermacs® centers.
8. Pediatric subjects (< 19 years of age).
9. Subjects who receive a temporary LVAD
10. Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.
11. Severe Right Heart failure
12. Aortic insufficiency or mechanical aortic valve.
13. Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).
14. Known LV Thrombus.

Disease(s) and\or Condition(s)

Left Sided Heart Failure

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DEVICE
- Name: HeartWare HVAD
- Description: Implant of HeartWare HVAD via thoracotomy implant technique
- Arm Group Labels: HeartWare HVAD via Thoracotomy
- Type: PROCEDURE
- Name: Thoracotomy
- Description: Thoracotomy implant technique
- Arm Group Labels: HeartWare HVAD via Thoracotomy

Sponsor

Medtronic Cardiac Rhythm and Heart Failure