HeartWare Device for Chronic Heart Failure
(DT PAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to confirm the safety and effectiveness of the HeartWare Ventricular Assist Device (HVAD System) in everyday medical practice. It focuses on patients scheduled to receive this device as a long-term treatment for heart failure. Ideal participants are those planning to have the HVAD System implanted as a permanent solution to improve heart function. As a Phase 4 trial, this research helps to understand how this FDA-approved and proven effective treatment benefits more patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the HeartWare Ventricular Assist Device?
Research shows that the HeartWare Ventricular Assist Device (HVAD) is generally safe for individuals with severe heart failure requiring long-term support. Studies have found that the HVAD can extend patients' lives and improve management of heart failure symptoms.
For instance, one study found encouraging survival rates six months after patients received the HVAD. Another study showed that most patients did well with the device, although some experienced side effects like bleeding or infections, common with any heart device.
Importantly, the FDA has approved the HVAD for use in patients with severe heart failure, indicating a strong safety record. While no treatment is without risk, the HVAD has been tested and used in many patients, demonstrating it is generally well-tolerated.12345Why are researchers enthusiastic about this study treatment?
The HeartWare Ventricular Assist Device (HVAD) is unique because it offers a mechanical solution for patients with severe heart failure who are not candidates for a heart transplant. Unlike traditional treatments such as medication or heart transplants, the HVAD is implanted into the heart to help it pump blood more effectively. Researchers are excited about this device because it is smaller and less invasive than previous ventricular assist devices, potentially leading to fewer complications and a quicker recovery time for patients. This innovation could significantly improve quality of life for those who have limited options due to their condition.
What evidence suggests that the HeartWare Ventricular Assist Device is effective for destination therapy?
Research has shown that the HeartWare Ventricular Assist Device (HVAD), which participants in this trial will receive, is a promising option for patients with severe heart failure who cannot undergo a heart transplant. One study found that using the HVAD as a long-term solution, known as destination therapy, helped these patients live longer and improved their quality of life. Another study found that while survival rates for HVAD patients were slightly lower than those waiting for transplants, the device still offers a valuable alternative. Overall, the HVAD system is recognized as a cost-effective treatment, providing significant benefits for people with serious heart conditions.24678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Monitoring
Participants are implanted with the HVAD System and monitored for initial safety and effectiveness
Long-term Follow-up
Participants are monitored for long-term safety and effectiveness, including stroke rates and device performance
Extended Follow-up
Participants continue to be monitored for complications and device performance until study closure or other endpoints
What Are the Treatments Tested in This Trial?
Interventions
- HeartWare Ventricular Assist Device
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Cardiac Rhythm and Heart Failure
Lead Sponsor
Geoff Martha
Medtronic Cardiac Rhythm and Heart Failure
Chief Executive Officer since 2020
MBA from University of Minnesota
Dr. Kweli Thompson
Medtronic Cardiac Rhythm and Heart Failure
Chief Medical Officer since 2022
MD from Harvard Medical School
Citations
1.
frontierspartnerships.org
frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2023.11675/fullFive-Year Outcome After Continuous Flow LVAD With Full ...
HM3) confirmed a significantly lower 5 years survival (41.7% vs. 64.1%; p 0.02), freedom from haemorrhagic stroke (90.5% vs. 70.1%; p < 0.001) ...
Cost-effectiveness of left ventricular assist devices as ...
Conclusions: The implantation of the HeartWare™ HVAD™ System in patients ineligible for cardiac transplantation as DT is a cost-effective ...
The HeartWare™ Ventricular Assist System as Destination ...
The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/ New York ...
Trends and Outcomes of Left Ventricular Assist Device ...
Patients implanted with a DT LVAD had lower 2-year survival compared with patients implanted as BTT (70.6% vs 78.3%; P < 0.01), likely due to ...
Outcomes of Left Ventricular Assist Devices as Destination ...
Conclusions: LVADs as destination therapy provide a viable option for improving the survival and quality of life of end-stage HF patients, despite the ...
HeartWare™ HVAD™ - System - accessdata.fda.gov
The objective of the trial was to compare the safety and effectiveness of HVAD for destination therapy to the HeartMate II, which is legally marketed in the ...
Clinical overview of the HVAD: a centrifugal continuous ...
The safety of HVAD implantation was evaluated by monitoring patient survival 180 days after implantation, or until LVAD explantation, cardiac transplantation, ...
8.
news.medtronic.com
news.medtronic.com/2017-09-27-Medtronic-HeartWare-TM-HVAD-TM-System-Approved-for-Destination-TherapyMedtronic HeartWare(TM) HVAD(TM) System Approved for ...
The data support the safety and effectiveness of the HeartWare HVAD System for patients with advanced, refractory left ventricular heart failure ...
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