Overview

This trial is active, not recruiting.

Condition left sided heart failure
Treatment heartware hvad
Sponsor HeartWare, Inc.
Collaborator INTERMACS
Start date November 2014
End date October 2016
Trial size 145 participants
Trial identifier NCT02268942, HW006 Thoracotomy

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 will be current INTERMACS® sites in good standing and will follow the INTERMACS® protocol and procedures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
HeartWare HVAD via Thoracotomy
heartware hvad

Primary Outcomes

Measure
Success Definition
time frame: Six Months

Eligibility Criteria

Male or female participants at least 19 years old.

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.

Additional Information

Official title 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 Advanced Heart Failure (HVAD LATERAL)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by HeartWare, Inc..