HW006 LATERAL Thoracotomy (HVAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Left Sided Heart Failure
• Intervention / Treatment: Device: HeartWare HVAD; Procedure: Thoracotomy

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • St. Paul's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University School of Medicine
    • San Diego, California, United States, 92093
      • UC San Diego
    • San Francisco, California, United States, 94143
      • UCSF Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa Transplant Institute/Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist
    • Indianapolis, Indiana, United States, 46262
      • St. Vincent Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital - Rudd Heart and Lung Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • John Ochsner Heart & Vascular Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Rochester - St. Mary's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital of Kansas City
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232-8802
      • Vanderbilt University Medical Center
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Richmond, Virginia, United States, 23298-0068
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98195-6310
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Length of Initial Hospital Stay	Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time	Initial Hospital Stay

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: INTERMACS

Publications and helpful links

General Publications

• Mahr C, McGee E Jr, Cheung A, Mokadam NA, Strueber M, Slaughter MS, Danter MR, Levy WC, Cheng RK, Beckman JA, May DM, Ismyrloglou E, Tsintzos SI, Silvestry SC. Cost-Effectiveness of Thoracotomy Approach for the Implantation of a Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):855-861. doi: 10.1097/MAT.0000000000001209. Erratum In: ASAIO J. 2021 Aug 1;67(8):e148.
• 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.
• Wieselthaler GM, Klein L, Cheung AW, Danter MR, Strueber M, Mahr C, Mokadam NA, Maltais S, McGee EC Jr. Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events. Circ Heart Fail. 2021 Apr;14(4):e006912. doi: 10.1161/CIRCHEARTFAILURE.120.006912. Epub 2021 Apr 19.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HW006 Thoracotomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes