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HW006 LATERAL Thoracotomy (HVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02268942
Recruitment Status : Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
INTERMACS
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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

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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 the 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
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Success Definition [ Time Frame: Six Months ]
    • Alive on the originally implanted device at 6 months, and the subject has not had a stroke with a modified Ranking Scale score ≥ 4 (assessed ≥ three months post-stroke event); or
    • Transplanted by Month 6 and the subject has not had a stroke with modified Ranking Scale score ≥ 4 (assessed ≥ three months post-stroke event); or
    • Explanted for recovery by Month 6 and the subject has not had a stroke with modified Ranking Scale score ≥ 4 (assessed ≥ three months post-stroke event).



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268942


  Show 26 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
INTERMACS

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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    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases