Heart FailureHW-PAS-03NCT01832610
Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 25 sites in United States.
Trial summary
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HeartWare® VAS
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 25 sitesUnited States
- Study dates
- Jan 2013to Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The patient population consists of patients who were at risk of death from refractory, advanced heart failure and implanted with a HeartWare® Ventricular Assist System under IDE G070199. Patients must have participated as a study patient in a prior HeartWare trial under IDE G070199, and been implanted with the HeartWare® System
Who may be able to join
- The patient has participated in a prior HeartWare trial under IDE G070199.
- The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
- The patient has signed informed consent for participation in the study.
Who cannot join
- The patient is unwilling or unable to comply with trial requirements.
- The patient did not sign the informed consent.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
The Emory Clinic Inc.
Atlanta, Georgia, 30322
Tufts Medical Center
Boston, Massachusetts, 02111
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
University of Texas - South Western
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida - Gainesville
Gainesville, Florida, 32610
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Texas Heart Institute
Houston, Texas, 77030
IU Health Methodist
Indianapolis, Indiana, 46202
Jewish Hospital - Rudd Heart and Lung Institute
Louisville, Kentucky, 40202
University of Miami / Jackson Memorial Hospital
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Northwest Cardiothoracic &Transplant Surgeons
Spokane, Washington, 99204
Washington University / Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University School of Medicine
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
Read the detailed description
Patients who participated in prior trials will be approached for this PAS as follows:
- Patients who are on continued HeartWare® System support, (original or exchange device)
- Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up
Patients who participated in prior trials who will not be approached to participate in this follow-up study include:
- Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).
No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.
- Conditions
- Heart Failure
- Being tested
- HeartWare® VAS
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWare® VASDevice
Also called HVAD®
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
| Study group | Role | What they receive |
|---|---|---|
| HeartWare® VAS | Ventricular Assist Device (HeartWare® VAS) Receives: Device: HeartWare® VAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival on Device
Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.
Measured: Implant to 5 years
Secondary outcomes (7)
Final Patient Status
The number and percentage of participants with a given outcome (e.g., alive on device, transplant, death, etc.) as of their last follow up or end of study, whichever occurred first.
Measured: Implant to 5 years
Re-hospitalizations
A summary of the number of re-hospitalizations per participant from enrollment into HW-PAS-03 throughout their participation in the study.
Measured: Enrollment into HW-PAS-03 to 5 years
Number of Participants Experiencing Any Adverse Event Per Intermacs Definition
Number of participants with an Intermacs adverse event, per the Intermacs definitions. An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the medical device.
Measured: Enrollment into HW-PAS-03 to 5 years
Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.
Measured: Change from baseline to 5 years
Health Status Change Measured by EuroQol EQ-5D (Version 5L)
The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worse imaginable health state) to 100 (best imaginable health state).
Measured: Enrollment to 5 years
Change in Functional Status Measured by New York Heart Association (NYHA) Class
Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA:
I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.
II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).
Measured: Change from baseline to 5 years
Change in Functional Status Measured by 6-minute Walk
Change in functional status, as measured by 6-minute walk test. A positive change in score from baseline indicates an improvement.
Measured: Change from baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Case only
- Time perspective
- Other
- Enrolment
- 101 participants (actual)
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
- NCT01832610
- Sponsor's protocol ID
- HW-PAS-03
- Acronym
- HW-PAS-03
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2013
- Last updated
- 11 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT01832610
- Acronym / sponsor ID
- HW-PAS-03 / HW-PAS-03
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jan 2013 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
Detailed description
Patients who participated in prior trials will be approached for this PAS as follows:
- Patients who are on continued HeartWare® System support, (original or exchange device)
- Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up
Patients who participated in prior trials who will not be approached to participate in this follow-up study include:
- Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).
No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartWare® VAS | – | Device: HeartWare® VASVentricular Assist Device (HeartWare® VAS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population consists of patients who were at risk of death from refractory, advanced heart failure and implanted with a HeartWare® Ventricular Assist System under IDE G070199. Patients must have participated as a study patient in a prior HeartWare trial under IDE G070199, and been implanted with the HeartWare® System
Key inclusion criteria (3 listed)
- The patient has participated in a prior HeartWare trial under IDE G070199.
- The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
- The patient has signed informed consent for participation in the study.
Key exclusion criteria (2 listed)
- The patient is unwilling or unable to comply with trial requirements.
- The patient did not sign the informed consent.
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® VASAlso: HVAD®The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use. | Device | HeartWare® VAS |
Primary outcome
Overall Survival on Device
Time frame: Implant to 5 years
Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.
7 secondary outcomes
Final Patient Status
Time frame: Implant to 5 years
Re-hospitalizations
Time frame: Enrollment into HW-PAS-03 to 5 years
Number of Participants Experiencing Any Adverse Event Per Intermacs Definition
Time frame: Enrollment into HW-PAS-03 to 5 years
Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Change from baseline to 5 years
Health Status Change Measured by EuroQol EQ-5D (Version 5L)
Time frame: Enrollment to 5 years
Change in Functional Status Measured by New York Heart Association (NYHA) Class
Time frame: Change from baseline to 5 years
Change in Functional Status Measured by 6-minute Walk
Time frame: Change from baseline to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 25 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 2 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: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival on Device (time frame: Implant to 5 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 11 Jul 2019.