Status:
COMPLETED
HW006 LATERAL Thoracotomy
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
INTERMACS
Conditions:
Left Sided Heart Failure
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry.
- Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).
- Subject signed an Intermacs® informed consent if required by local IRB policy.
- Subject signed a HeartWare informed consent.
Exclusion
- Subject is incarcerated (prisoner).
- Subject did not sign the informed consent at sites where waiver of consent was not granted.
- Body Surface Area (BSA) \< 1.2 m\^2.
- Prior cardiac transplant or cardiomyoplasty.
- Subject is receiving a BiVAD.
- Subject is receiving the device as an RVAD.
- Subject data is generated from non- Intermacs® centers.
- Pediatric subjects (\< 19 years of age).
- Subjects who receive a temporary LVAD
- Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.
- Severe Right Heart failure
- Aortic insufficiency or mechanical aortic valve.
- Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).
- Known LV Thrombus.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT02268942
Start Date
November 1 2014
End Date
October 1 2018
Last Update
December 2 2019
Active Locations (26)
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1
The University of Alabama
Birmingham, Alabama, United States, 35294
2
Stanford University School of Medicine
Palo Alto, California, United States, 94305
3
UC San Diego
San Diego, California, United States, 92093
4
UCSF Medical Center
San Francisco, California, United States, 94143