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OpenTrials
Completed

NCT Number: NCT02268942

HW006 LATERAL Thoracotomy

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.

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Key information

Conditions

Left Sided Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HeartWare HVAD

Device

Implant of HeartWare HVAD via thoracotomy implant technique

thoracotomy

Procedure

Thoracotomy implant technique

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • INTERMACS

Registry information

Official study 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

Acronym: HVAD

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Oct 20, 2014
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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