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

NCT02268942•Medtronic Cardiac Rhythm and Heart Failure

View on ClinicalTrials.gov

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (26)

The University of Alabama

Birmingham, Alabama, United States

Stanford University School of Medicine

Palo Alto, California, United States

UC San Diego

San Diego, California, United States

UCSF Medical Center

San Francisco, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Tampa Transplant Institute/Tampa General Hospital

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

IU Health Methodist

Indianapolis, Indiana, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

Key Dates

Start Date

November 1, 2014

Primary Completion Date

October 1, 2016

Completion Date

October 1, 2018

Last Updated

December 2, 2019

Enrollment

144

ACTUAL participants

Conditions

Left Sided Heart Failure

Interventions

HeartWare HVAD

DEVICE

Thoracotomy

PROCEDURE