Chronic Heart FailureDT PASNCT03681210
Destination Therapy Post Approval Study
An observational study of Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 47 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- HeartWare Ventricular Assist Device
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 47 sitesUnited States
- Study dates
- 31 Oct 2018to Apr 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
- Patient less than 18 years of age.
- Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
University of Colorado
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611-2969
The Lindner Christ Hospital
Cincinnati, Ohio, 45219-2906
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1240
University of Miami
Coral Gables, Florida, 33146
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
Dallas, Texas, 75204
University of Texas Southwestern Medical Center
Dallas, Texas, 75389
Henry Ford Health System
Detroit, Michigan, 48202
PennState Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas Health Sciences Center
Houston, Texas, 77030
Saint Vincent Medical Group
Indianapolis, Indiana, 46260
Mayo Clinic (Jacksonville FL)
Jacksonville, Florida, 32224
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205
University of Louisville Hospital
Louisville, Kentucky, 40202
Loyola University
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone Medical Center
New York, New York, 10016
Columbia University
New York, New York, 10032
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center (Cardiac Surgery Clinical Research Center)
Oak Lawn, Illinois, 60453
University of Nebraska Medical Center
Omaha, Nebraska, 68198
AdventHealth
Orlando, Florida, 32804
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84132
Methodist Hospital San Antonio
San Antonio, Texas, 78229
University of California San Diego
San Diego, California, 92103
University of California San Francisco Medical Center
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Hospital
Stanford, California, 94305-5330
University of South Florida Health
Tampa, Florida, 33606
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Westchester Medical Center
Valhalla, New York, 10595
About this study
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.
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- HeartWare Ventricular Assist Device
- Keywords
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWare Ventricular Assist DeviceDevice
Also called HVAD
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HeartWare Ventricular Assist Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term complication free survival
Complications include death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation.
Measured: Implant to 2 years
Secondary outcomes (3)
Rate of stroke
The rate of stroke on device will be analyzed using Kaplan-Meier methods.
Measured: Implant to 2 years
Rate of late stroke
The rate of late stroke on device will be analyzed using Kaplan-Meier methods for those surviving stroke-free for 24 months post-implant.
Measured: 2 years post-implant to 5 years
Stroke severity
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.
Measured: Occurrence of stroke to 24 weeks post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start31 Oct 2018
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681210
- Sponsor's protocol ID
- DT PAS
- Acronym
- DT PAS
- Status last verified
- Jul 2025
- First submitted
- 20 Sep 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Destination Therapy Post Approval Study
- ClinicalTrials.gov ID
- NCT03681210
- Acronym / sponsor ID
- DT PAS / DT PAS
- Conditions
- Chronic Heart Failure
- Keywords
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with HVAD System | – | Device: HeartWare Ventricular Assist DevicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
- Patient less than 18 years of age.
- Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartWare Ventricular Assist DeviceAlso: HVADThe 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). | Device | Patients implanted with HVAD System |
Primary outcome
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.
3 secondary outcomes
Rate of stroke
Time frame: Implant to 2 years
Rate of late stroke
Time frame: 2 years post-implant to 5 years
Stroke severity
Time frame: Occurrence of stroke to 24 weeks post-stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term complication free survival (time frame: Implant to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.