HW006 LATERAL Thoracotomy (HVAD)

• ClinicalTrials.gov Identifier: NCT02268942
• Recruitment Status: Completed
• First Posted: October 20, 2014
• Results First Posted: November 11, 2019
• Last Update Posted: December 2, 2019
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborator: INTERMACS
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Left Sided Heart Failure	Device: HeartWare HVAD; Procedure: Thoracotomy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 144 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: November 2014
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: HeartWare HVAD via Thoracotomy; HeartWare HVAD implanted via thoracotomy	Device: HeartWare HVAD; Implant of HeartWare HVAD via thoracotomy implant technique; Procedure: Thoracotomy; Thoracotomy implant technique

Outcome Measures

Primary Outcome Measures :

1. Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months [ Time Frame: 6 months ]
   • Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or

   • Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale

     ≥ 4 (assessed ≥ three months post-stroke event); or

   • Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event).

Secondary Outcome Measures :

1. Mean Length of Initial Hospital Stay [ Time Frame: Initial Hospital Stay ]
   Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

  Show 26 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

INTERMACS

  Study Documents (Full-Text)

Documents provided by Medtronic Cardiac Rhythm and Heart Failure:

Study Protocol  [PDF] October 24, 2018

Statistical Analysis Plan  [PDF] February 22, 2017

More Information

Publications of Results:

McGee E Jr, Danter M, Strueber M, Mahr C, Mokadam NA, Wieselthaler G, Klein L, Lee S, Boeve T, Maltais S, Pretorius GV, Adler E, Vassiliades T, Cheung A. Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial. J Heart Lung Transplant. 2019 Apr;38(4):344-351. doi: 10.1016/j.healun.2019.02.002.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT02268942 History of Changes
• Other Study ID Numbers: HW006 Thoracotomy
• First Posted: October 20, 2014
• Results First Posted: November 11, 2019
• Last Update Posted: December 2, 2019
• Last Verified: November 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases