Destination Therapy Post Approval Study (DT PAS)

• ClinicalTrials.gov Identifier: NCT03681210
• Recruitment Status: Recruiting
• First Posted: September 24, 2018
• Last Update Posted: September 12, 2019
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Heart Failure	Device: HeartWare Ventricular Assist Device

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: Destination Therapy Post Approval Study
• Actual Study Start Date: October 31, 2018
• Estimated Primary Completion Date: November 2025
• Estimated Study Completion Date: November 2025

Groups and Cohorts

Group/Cohort

Intervention/treatment

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.

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Rate of stroke [ Time Frame: Implant to 2 years ]
   The rate of stroke on device will be analyzed using Kaplan-Meier methods.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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)

Contacts and Locations

Contacts

Contact: DT PAS Manager; 508-532-4722; samantha.ly@medtronic.com

  Show 41 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

More Information

Additional Information:

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT03681210 History of Changes
• Other Study ID Numbers: DT PAS
• First Posted: September 24, 2018
• Last Update Posted: September 12, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:

Heart Failure; Heart Diseases; Cardiovascular Diseases

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases