What side effects are associated with this type of intervention?

The most common treatment for tricuspid regurgitation, particularly in the context of the trial studying surgical correction during LVAD implantation, is surgical repair or replacement of the tricuspid valve. Known side effects of surgical correction of TR can include bleeding, infection, arrhythmias, thromboembolic events, and complications related to anesthesia. Additionally, there may be risks of valve dysfunction or failure, and in some cases, the need for reoperation. These side effects are generally consistent with those observed in other types of cardiac valve surgeries.

What prior FDA approvals exist?

The FDA has approved several treatments for tricuspid regurgitation, primarily focusing on surgical and device-based interventions. One notable approval is the use of transcatheter tricuspid valve repair systems, such as the TriClip device, which is designed to reduce tricuspid regurgitation by clipping together portions of the tricuspid valve leaflets. Additionally, surgical correction methods, including tricuspid valve repair and replacement, are standard treatments aimed at improving valve function and reducing right ventricular dysfunction. These interventions are similar to those being studied in trials evaluating the impact of surgical correction of tricuspid valve regurgitation on right ventricular function.

What other types of research exist?

Promising, novel alternatives to surgical correction of tricuspid valve regurgitation for 2024 include: 1) Transcatheter tricuspid valve repair (e.g., edge-to-edge repair using devices like the MitraClip adapted for the tricuspid valve), 2) Transcatheter tricuspid valve replacement (using dedicated transcatheter valves), 3) Percutaneous annuloplasty devices (e.g., Cardioband), and 4) Emerging pharmacological treatments targeting the underlying causes of TR and right ventricular dysfunction.

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Device

Tricuspid Valve Repair + LVAD for Heart Failure

N/A

Recruiting

Led By Kei Togashi, MD, MPH

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD

Over 18 years of age

Must not have

History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis

Participant refuses to be enrolled in study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include complications from surgery such as infection or bleeding; potential worsening of heart function; reactions to anesthesia; and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not want to participate in the study.

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I have a mechanical aortic valve and it won't be replaced during my heart pump implant.

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I have had surgery to fix my tricuspid valve before.

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I am on long-term dialysis for my kidneys.

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I have an ongoing infection that isn't under control.

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My heart's tricuspid valve has a structural problem.

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I have had a heart transplant or surgery to repair my heart muscle.

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I do not have any health conditions that could shorten my life to under a year, aside from heart failure.

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My liver tests show abnormal results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in TR severity assessment from baseline

Secondary study objectives

Change in RV function from baseline

Change in quality of life (QOL) from baseline

Other study objectives

Duration of hospitalization after implant

Incidence of inotropic infusions

Incidence of serious adverse events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LVAD+TVRExperimental Treatment2 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 onlyActive Control1 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.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Tricuspid Regurgitation (TR) include surgical valve repair and valve replacement. Valve repair typically involves techniques such as annuloplasty, where a ring is used to tighten or reinforce the valve annulus, thereby improving valve closure and reducing regurgitation. Valve replacement involves substituting the damaged tricuspid valve with a prosthetic valve, which can be either mechanical or bioprosthetic. These treatments are crucial for TR patients as they aim to restore proper valve function, reduce the backward flow of blood, and alleviate symptoms such as fatigue and right heart failure. Improved valve function can enhance overall cardiac efficiency and quality of life, particularly in patients undergoing procedures like LVAD implantation, where right ventricular function is critical.