Tricuspid Valve Repair + LVAD for Heart Failure

Recruiting in Palo Alto (17 mi)

Overseen by Kei Togashi, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

Disqualifiers: Pregnancy, Stroke, Infection, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether fixing a leaky heart valve during the implantation of a heart pump can help patients who have mild to moderate valve issues. The goal is to see if this combined approach improves heart function and reduces complications after surgery.

Will I have to stop taking my current medications?

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 data supports the effectiveness of the treatment Tricuspid Valve Repair + LVAD for Heart Failure?

Research shows that using a left ventricular assist device (LVAD) like HeartMate II or HeartMate 3 can significantly improve survival in patients with severe heart failure. Additionally, combining LVAD with tricuspid valve repair has been successfully used in some cases, although it may increase the risk of temporary right heart support.

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Is the combination of Tricuspid Valve Repair and LVAD generally safe for humans?

Research shows that the HeartMate II and HeartMate 3 LVADs have been used safely in patients with advanced heart failure, with studies focusing on outcomes like stroke and mortality. The HeartMate 3, in particular, has been evaluated for safety and effectiveness, and the combination with tricuspid valve procedures has been assessed for safety in patients with these devices.

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How is the treatment of tricuspid valve repair with LVAD unique for heart failure?

This treatment is unique because it combines tricuspid valve repair with the implantation of a left ventricular assist device (LVAD), which helps the heart pump blood. This approach addresses both the mechanical support of the heart and the repair of valve issues, which may improve outcomes for patients with heart failure.

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Eligibility Criteria

This trial is for adults over 18 with advanced heart failure symptoms who are scheduled for an LVAD implant and have mild tricuspid regurgitation. It's not for pregnant individuals, those with psychiatric or severe cognitive issues, uncontrolled infections, other life-limiting conditions, high surgical risk as judged by the investigator, participation in confounding studies, inmates, liver disease patients, recent stroke victims or significant cerebral vascular disease sufferers.

Inclusion Criteria

I have severe heart failure and am getting an LVAD implant.

Participant or their legal representative has signed an informed consent

I am over 18 years old.

Exclusion Criteria

Pregnancy

I have not had a stroke or significant blockage in my brain's blood vessels in the last 3 months.

You are currently using any mechanical heart support other than an intra-aortic balloon pump.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-randomization

Participants undergo medical history, physical exam, and echocardiogram prior to randomization

4 weeks

1 visit (in-person)

Treatment

Participants receive LVAD implantation with or without tricuspid valve repair

10 days

Inpatient stay

Follow-up

Participants are monitored for changes in RV function, TR severity, and quality of life

13 months

Regular follow-up visits

Participant Groups

The study examines if surgically fixing the tricuspid valve at the same time as implanting a left ventricular assist device (LVAD) can improve health outcomes. Researchers will monitor how well the repaired valve works post-surgery and look at patient recovery times and quality of life.

Group I: LVAD+TVR Experimental Treatment 2 Interventions

In addition to left ventricular assist device (LVAD) placement with the inflow cannula in the left ventricular apex and outflow cannula placed in the ascending aorta, a repair of the regurgitating tricuspid valve will be performed. A Patent Foramen Ovale, if present, will be closed primarily. Echocardiographic parameters relevant to study will be collected throughout the procedure.

Group II: LVAD only Active Control 1 Intervention

LVAD placement will be performed without additional tricuspid valve repair (TVR). The inflow cannula will be sutured to the left ventricular apex followed by the outflow cannula placed in the ascending aorta. This will be performed under cardiopulmonary bypass. Echocardiographic parameters relevant to study will be collected throughout the procedure.

Left ventricular assist device (LVAD) is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Left ventricular assist device for:

• Advanced heart failure
• Bridge to heart transplantation
• Destination therapy

🇺🇸 Approved in United States as Left ventricular assist device for:

• Advanced heart failure
• Bridge to heart transplantation
• Destination therapy

🇨🇦 Approved in Canada as Left ventricular assist device for:

• Advanced heart failure
• Bridge to heart transplantation
• Destination therapy

🇯🇵 Approved in Japan as Left ventricular assist device for:

• Advanced heart failure
• Bridge to heart transplantation
• Destination therapy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Washington Medical Center Seattle, WA

Who Is Running the Clinical Trial?

University of Washington Lead Sponsor

Society of Cardiovascular Anesthesiologists Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Device exchange from Heartmate II to HeartWare HVAD. [2020] Despite technological advancements, pump durability and pump-related complications continue to affect and adversely impact the lives of patients with end-stage heart failure on left ventricular assist device (LVAD) support. In an attempt to avoid recurrent LVAD-related complications, there may be circumstances where it is clinically advantageous to exchange a patient's device from HeartMate II to HeartWare HVAD. However, there is a paucity of data that describes the safety and feasibility of such an approach.

2. Germany pubmed.ncbi.nlm.nih.gov

Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis. [2021] The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support).

3. Germany pubmed.ncbi.nlm.nih.gov

Concomitant tricuspid valve repair in left ventricular assist device implantation may increase the risk for temporary right ventricular support but does not impact overall outcomes. [2023] Tricuspid valve repair in left ventricular assist device implantation continues to pose a challenge and may impact the occurrence of early and late right heart failure. We investigated the effects of concomitant tricuspid repair on clinical outcomes.

4. England pubmed.ncbi.nlm.nih.gov

HeartWare to HeartMate 3 left ventricular assist device exchange via a left lateral thoracotomy. [2022] A continuous-flow left ventricular assist device implant is a well-established therapy for patients with end-stage heart failure. Currently, the HeartMate 3 device is the only commercially available durable left ventricular assist device. Therefore, patients on HeartWare HVAD support who require a pump exchange must have a HeartMate 3 implanted.

5. South Africa pubmed.ncbi.nlm.nih.gov

Successful continuous-flow left ventricular assist device implantation with adjuvant tricuspid valve repair for advanced heart failure. [2018] The prevalence of end-stage heart failure (HF) is on the increase, however, the availability of donor hearts remains limited. Left ventricular assist devices (LVADs) are increasingly being used for treating patients with end-stage HF. LVADs are not only used as a bridge to transplantation but also as a destination therapy. HeartMate II, a new-generation, continuous-flow LVAD (cf-LVAD), is currently an established treatment option for patients with HF. Technological progress and increasing implantation of cf-LVADs have significantly improved survival in patients with end-stage HF. Here we report a case of a patient with end-stage HF who was successfully supported using cf-LVAD implantation with adjuvant tricuspid valve repair in a general district hospital.

6. United States pubmed.ncbi.nlm.nih.gov

In-hospital stroke and mortality trends after left ventricular assist device implantation in the United States from 2017 to 2019. [2023] The newer Left Ventricular Assist Device (LVAD), the HeartMate 3 (HM3), was initially approved by the Food and Drug Administration in 2017. We aimed to describe the temporal trends of in-hospital stroke and mortality among patients who underwent LVAD placement between 2017 and 2019.

7. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of tricuspid valve insufficiency promotes early reverse remodeling in patients with axial-flow left ventricular assist devices. [2022] The HeartMate II (Thoratec Corp, Pleasanton, Calif) continuous-flow left ventricular assist device has emerged as the standard of care for patients with advanced heart failure. The objective of this study was to assess the safety and early effectiveness of concomitant tricuspid valve procedures in patients undergoing implantation of a HeartMate II device.

8. Germany pubmed.ncbi.nlm.nih.gov

Retrospective 1-year outcome follow-up in 200 patients supported with HeartMate 3 and HeartWare left ventricular assist devices in a single centre. [2021] Various trials have assessed the outcome and reliability of the HeartWare HVAD (HW) and HeartMate 3 (HM3) left ventricular assist devices. A direct comparison of clinical outcomes and of the complication profile of these 2 left ventricular assist devices is lacking. We present a retrospective analysis of patients supported with HM3 and HW as a left ventricular assist device.

9. Germany pubmed.ncbi.nlm.nih.gov

European results with a continuous-flow ventricular assist device for advanced heart-failure patients. [2019] The HeartMate II (HM II) LVAD is a small, quiet, continuous-flow, left ventricular assist device (LVAD) for circulatory support in advanced heart-failure patients, with over 2000 implants worldwide. This article reports on the European experience with this device.

10. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes with the HeartMate 3 left ventricular assist device. [2019] The HeartMate 3 (HM3; Abbott Laboratories, Lake Forest, Ill) left ventricular assist device (LVAD) received its Conformité Européenne mark for Europe in October 2015 and is currently under investigation of the Food and Drug Administration to gain approval in the United States. Within this study, we present the first real-world experiences, 1-year outcomes, and adverse events of a single-center cohort treated with the HM3.

11. China pubmed.ncbi.nlm.nih.gov

Concomitant cardiac surgery procedures during left ventricular assist device implantation: single-centre experience. [2022] Additional cardiac pathologies including tricuspid or mitral valve regurgitation are common in left ventricular assist device (LVAD) recipients and whether to address them remains controversial. We present our institutional outcomes of concomitant cardiac procedures, other than temporary right ventricular (RV) support, at the time of LVAD implantation.

12. United States pubmed.ncbi.nlm.nih.gov

Relationship of tricuspid repair at the time of left ventricular assist device implantation and survival. [2022] Tricuspid regurgitation contributes to right ventricular failure (RVF) and is associated with worse clinical outcomes in patients undergoing left ventricular assist device (LVAD) treatment. However, whether tricuspid valve repair (TVR) at the time of LVAD implantation improves outcomes is not clear.

13. United States pubmed.ncbi.nlm.nih.gov

Durability and Efficacy of Tricuspid Valve Repair in Patients Undergoing Left Ventricular Assist Device Implantation. [2021] This study sought to determine the durability of tricuspid valve repair (TVr) performed concurrently with left ventricular assist device (LVAD) implantation and its association with the development of late right heart failure (RHF).