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Destination Therapy Post Approval Study (DT PAS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03681210
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date September 20, 2018
First Posted Date September 24, 2018
Last Update Posted Date April 24, 2020
Actual Study Start Date October 31, 2018
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2018)
Long-term complication free survival [ Time Frame: Implant to 2 years ]
Complications include death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 20, 2018)
  • Rate of stroke [ Time Frame: Implant to 2 years ]
    The rate of stroke on device will be analyzed using Kaplan-Meier methods.
  • Rate of late stroke [ Time Frame: 2 years post-implant to 5 years ]
    The rate of late stroke on device will be analyzed using Kaplan-Meier methods for those surviving stroke-free for 24 months post-implant.
  • Stroke severity [ Time Frame: Occurrence of stroke to 24 weeks post-stroke ]
    Modified Rankin Scale (mRS) scores will be collected at the time associated with stroke on device and at 12 and 24 weeks post-stroke. The distribution of mRS scores for all strokes occurring in the study will be presented, separating stroke occurring prior to 24 months post-implant and those occurring greater than 24 months post-implant.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Destination Therapy Post Approval Study
Official Title Destination Therapy Post Approval Study
Brief Summary

Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice.

The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.

Detailed Description The HeartWare Destination Therapy (DT) Post Approval Study (PAS) is a prospective, observational, multi-site study. Enrollment into the DT PAS will be comprised of newly enrolled, commercial use DT patients with the HeartWare Ventricular Assist Device System (HVAD System). Patients enrolled in DT PAS will be followed for 5 years post-implant or until study closure, patient death, patient exit from the PAS (i.e., withdrawal of consent), or patient has HVAD device removed without replacement (i.e., transplant, recovery) or device is exchanged for non-HVAD. The total estimated study duration is approximately 7 years.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients intended to be implanted with a HVAD for use as a destination therapy are eligible for enrollment into the DT PAS and must be consented for the PAS prior to the HVAD implant. The PAS cohort will be comprised of 300 newly enrolled PAS patients.
Condition Chronic Heart Failure
Intervention Device: HeartWare Ventricular Assist Device
The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
Other Name: HVAD
Study Groups/Cohorts Patients implanted with HVAD System
Patients intended to be implanted with a HVAD for use as destination therapy are eligible for enrollment into the DT PAS and must be consented for the study prior to the HVAD implant.
Intervention: Device: HeartWare Ventricular Assist Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 20, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2025
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient is intended to receive or be treated with a HeartWare HVAD System for use as destination therapy
  • Patient is consented prior to the HVAD implant procedure

Exclusion Criteria:

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and or effectiveness)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: DT PAS Manager 508-532-4722 samantha.ly@medtronic.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03681210
Other Study ID Numbers DT PAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date April 2020