N/A
N=144
HW006 LATERAL Thoracotomy
Left Sided Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02268942 ↗Enrolled (actual)
144
Serious AEs
93.1%
Results posted
Nov 2019
Primary outcome: Primary: Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months — 128 Participants — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HeartWare HVAD (Device); Thoracotomy (Procedure)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months |
128 | 0.0003 sig |
| SECONDARY Mean Length of Initial Hospital Stay |
17.8 | <0.0001 sig |
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 Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02268942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.