Tricuspid Valve Repair + LVAD for Heart Failure

Overseen By Cynthia Wu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Pregnancy, Stroke, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether repairing a leaky tricuspid valve (a heart valve that can let blood flow backward) during the implantation of a left ventricular assist device (LVAD) improves outcomes for people with serious heart failure. Researchers aim to determine if this additional repair reduces problems with the right side of the heart and enhances overall health and recovery. The trial will compare patients receiving the LVAD alone with those receiving both the LVAD and valve repair. Eligible participants include those with advanced heart failure symptoms and mild tricuspid valve leakage, who are already scheduled to receive an LVAD.

As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance future heart failure treatments.

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 prior data suggests that this procedure is safe for heart failure patients?

Research has shown that combining a tricuspid valve repair (TVR) with a left ventricular assist device (LVAD) can improve outcomes for heart failure patients. Some studies found that this combination is well-tolerated and the repair remains durable, indicating a low risk of complications from the repair itself.

Other studies have demonstrated that using an LVAD can significantly enhance survival rates in patients with severe heart conditions. Newer LVADs, such as the HeartMate II or HeartMate 3, are smaller and more durable, aiding in better patient recovery.

These findings suggest that the combination of TVR and LVAD is generally safe. However, since each patient is unique, discussing specific health needs with a doctor is important before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine the use of a left ventricular assist device (LVAD) with a tricuspid valve repair (TVR) to address heart failure more comprehensively. Unlike standard heart failure treatments that might focus solely on supporting the left ventricle with an LVAD, this approach also tackles the often-overlooked issue of tricuspid valve regurgitation, which can significantly impact heart function. By repairing the tricuspid valve and closing any existing Patent Foramen Ovale, this treatment aims to improve blood flow dynamics and potentially enhance overall heart performance. This dual-action strategy could offer better outcomes for patients struggling with complex heart failure scenarios.

What evidence suggests that this trial's treatments could be effective for heart failure?

This trial will compare two treatment approaches for heart failure: the implantation of a left ventricular assist device (LVAD) alone and the combination of LVAD implantation with tricuspid valve repair (TVR). Research has shown that fixing the tricuspid valve (TV) during LVAD implantation can be beneficial. Studies have found that repairing the valve helps the heart function better and reduces the risk of complications after surgery. The repair also tends to last a long time, which is promising for patients' health. Evidence suggests that fixing the valve can improve survival rates, especially when the valve leak is severe. However, more research is needed to understand the effects of repairing mild to moderate leaks during LVAD procedures. ^{2 4 6 7 8}

Who Is on the Research Team?

Kei Togashi, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

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

Pregnancy

Your body weight is very high for your height.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Left ventricular assist device (LVAD)
• Tricuspid Valve Repair (TVR)

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Society of Cardiovascular Anesthesiologists

Collaborator

Trials

3

Recruited

5,600+

Published Research Related to This Trial

In a study of 101 patients undergoing LVAD implantation, those who received tricuspid valve repair (TVR) showed a significant improvement in survival rates compared to those who did not, with a hazard ratio of 0.1 (p = 0.049).

Despite the survival benefit, there was no significant difference in the incidence of right ventricular failure (RVF) between the TVR and non-TVR groups, suggesting that while TVR may enhance survival, it does not necessarily prevent RVF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of tricuspid repair at the time of left ventricular assist device implantation and survival. Brewer, RJ., Cabrera, R., El-Atrache, M., et al.[2022]

In a study of 156 patients who underwent tricuspid valve repair (TVr) during left ventricular assist device (LVAD) implantation, 37.8% experienced failure of the TVr, indicating a significant rate of recurrence of tricuspid regurgitation (TR).

The failure of TVr was found to be an independent predictor of late right heart failure (RHF), with a hazard ratio of 2.62, suggesting that patients with failed TVr are at a higher risk for developing late RHF after LVAD surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability and Efficacy of Tricuspid Valve Repair in Patients Undergoing Left Ventricular Assist Device Implantation. Barac, YD., Nicoara, A., Bishawi, M., et al.[2021]

In a study of 83 patients with advanced heart failure, those who underwent a concomitant tricuspid valve procedure during HeartMate II implantation experienced a significant reduction in tricuspid regurgitation by 50.2% after one month, compared to a worsening of 18.6% in those who did not have the procedure.

The tricuspid valve procedure also led to improvements in right ventricular remodeling, as indicated by a significant reduction in right ventricular end-diastolic area, while overall survival rates were similar between both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of tricuspid valve insufficiency promotes early reverse remodeling in patients with axial-flow left ventricular assist devices. Maltais, S., Topilsky, Y., Tchantchaleishvili, V., et al.[2022]

The study presents the largest single-center experience of exchanging a HeartMate II (HMII) LVAD for a HeartWare (HVAD) device, involving 11 male patients with a mean age of 55 years, demonstrating that this exchange can be performed safely with manageable postoperative complications.

Despite one early postoperative death due to sepsis, the overall outcomes were acceptable, with no patients requiring further device exchanges or heart transplants during the follow-up period, which averaged over 1555 days for the remaining patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device exchange from Heartmate II to HeartWare HVAD. Beaupre, RA., Alnajar, A., Sugiura, T., et al.[2020]

The HeartMate II (HM II) LVAD has been successfully implanted in 571 patients across Europe, showing a 69% overall survival rate to transplantation, recovery, or ongoing support, with a mean support duration of 236 days.

While the HM II LVAD is effective for long-term support in advanced heart failure, there are notable adverse events, including high rates of bleeding (42-59%) and infections, indicating a need for improved management of these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European results with a continuous-flow ventricular assist device for advanced heart-failure patients. Lahpor, J., Khaghani, A., Hetzer, R., et al.[2019]

In a study of 27 patients receiving the HeartMate 3 (HM3) left ventricular assist device, the 1-year survival rate was 85.2%, with no cases of pump thrombosis or strokes reported, indicating a strong safety profile.

The main complication observed was LVAD-related infection in 22.2% of patients, but overall, the HM3 demonstrated excellent midterm outcomes with no technical complications or need for pump exchanges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes with the HeartMate 3 left ventricular assist device. Hanke, JS., Dogan, G., Zoch, A., et al.[2019]

A retrospective analysis of 200 patients (100 with HeartWare HVAD and 100 with HeartMate 3) showed that while early survival rates at one year were similar for both devices (62.2% for HW and 66.7% for HM3), the complication profiles differed significantly.

Patients with the HeartWare HVAD experienced a higher incidence of cerebral bleeding and hemocompatibility-related adverse events compared to those with the HeartMate 3, indicating that while both devices are effective, the HeartMate 3 may have a safer profile regarding certain complications.

NCBI (Pubmed)

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. Mueller, M., Hoermandinger, C., Richter, G., et al.[2021]

In a study of 352 adult patients undergoing LVAD implantation, 24% had concomitant cardiac procedures, primarily tricuspid valve annuloplasty, which was associated with higher in-hospital mortality (22% vs. 14%) compared to those without additional surgeries.

Despite the increased perioperative risks, one-year survival rates were similar between patients who had concomitant procedures and those who did not (71% vs. 79%), suggesting that while these procedures may complicate the immediate recovery, they do not significantly impact long-term survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant cardiac surgery procedures during left ventricular assist device implantation: single-centre experience. Riebandt, J., Schaefer, A., Wiedemann, D., et al.[2022]

In a study of 526 patients who received left ventricular assist devices, 21% underwent concomitant tricuspid valve repair, which was associated with a higher incidence of early right heart failure requiring temporary right ventricular assist devices (18% vs. 11%).

Despite the increased risk of early right heart failure, the study found no significant differences in long-term outcomes such as rehospitalizations or mortality between patients who had tricuspid repair and those who did not.

NCBI (Pubmed)

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. Mihalj, M., Jezovnik, MK., Benk, J., et al.[2023]

From 2017 to 2019, in-hospital mortality rates for patients receiving the HeartMate 3 Left Ventricular Assist Device (LVAD) decreased significantly, showing a trend of -1.8% per year, indicating improved survival outcomes.

Despite the decrease in mortality, the rates of in-hospital strokes (both ischemic and hemorrhagic) did not show significant changes, suggesting that while LVADs improve survival, they are still associated with a higher risk of stroke (almost double the odds compared to those without LVAD).

NCBI (Pubmed)

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. Lopez, J., Mark, J., Wahood, W., et al.[2023]

In a study comparing the HeartWare HVAD and HeartMate3 devices, mid-term survival rates were similar for both devices, with 2-year survival at 61% for HVAD and 68% for HeartMate3, indicating comparable efficacy in supporting patients with severe heart failure.

However, patients using the HeartWare HVAD experienced a significantly higher risk of complications, including device malfunction, neurological dysfunction, and intracranial bleeding, suggesting that while survival rates are similar, the safety profile of HVAD may be concerning.

NCBI (Pubmed)

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. Potapov, EV., Nersesian, G., Lewin, D., et al.[2021]

The HeartMate 3 is currently the only commercially available durable left ventricular assist device for patients with end-stage heart failure, highlighting its importance in treatment options.

Patients needing a pump exchange from the HeartWare HVAD must transition to the HeartMate 3, indicating its central role in ongoing heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HeartWare to HeartMate 3 left ventricular assist device exchange via a left lateral thoracotomy. Nersesian, G., Montagner, M., Lanmueller, P., et al.[2022]

Left ventricular assist devices (LVADs), particularly the HeartMate II continuous-flow LVAD, are becoming increasingly important in treating patients with end-stage heart failure, serving both as a bridge to transplantation and as a long-term therapy.

The successful implantation of a cf-LVAD, along with tricuspid valve repair, demonstrates the effectiveness of this technology in improving survival rates for patients with severe heart failure, even in general district hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful continuous-flow left ventricular assist device implantation with adjuvant tricuspid valve repair for advanced heart failure. Lee, CH., Wei, J.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6995411/

Durability and Efficacy of Tricuspid Valve Repair in Patients ... This study sought to determine the durability of tricuspid valve repair (TVr) performed concurrently with left ventricular assist device (LVAD) implantation.

2. sites.withpower.com sites.withpower.com/trial/phase-heart-failure-7-2015-30cf1

Tricuspid Valve Repair + LVAD for Heart Failure 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.

3. mdpi.com mdpi.com/2077-0383/13/5/1411

Durability of Tricuspid Valve Repair in Patients Undergoing ... Contrary to expectations, concomitant TVR during LVAD implantation may result in excellent repair durability, which appears to be associated with low risk for ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/aor.14819

Concomitant tricuspid valve surgery in patients with ... This study compares early and late mortality and RHF outcomes in patients with significant TR undergoing LVAD implantation with and without concomitant TVS.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022522315017912

Durability and clinical impact of tricuspid valve procedures ... Long-term outcomes of concurrent tricuspid valve procedures in continuous-flow left ventricular assist device implantation are unclear. Methods. From May 2004 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21211999/

Tricuspid valve repair with left ventricular assist device ... This study was designed to evaluate the effect on outcomes of concomitant tricuspid valve repair (TVR) for moderate to severe (3(+)/4(+)) TR at the time of LVAD ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12059792/

Structural Heart Interventions in Patients with Left Ventricular ... This review provides a comprehensive approach for diagnosing and treating structural heart disease associated with patients who have LVADs.

8. jhltonline.org jhltonline.org/article/S1053-2498(24)01279-8/pdf

Outcomes of Concomitant Tricuspid Valve ... 13 patients underwent aortic valve replacement and 2 Bentall procedure. Implanted permanent. VAD devices were HVAD and Heart Mate 3 (HM3) (group 1: HVAD: 93.4%, ...