TRAIPTA Procedure for Tricuspid Regurgitation

Recruiting at 3 trial locations

Overseen By Annette M Stine, R.N.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Prior cardiac surgery, Severe mitral regurgitation, Left ventricular dysfunction, Severe pulmonary hypertension, others

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

Compensation: Varies

Number of Visits: 6

Duration: 1 day

60 Participants Needed

Trial Summary

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 TRAIPTA treatment for tricuspid regurgitation?

The research highlights a significant need for lower-risk transcatheter solutions for tricuspid regurgitation (TR) due to high risks associated with surgical management. Although percutaneous tricuspid valve interventions are still developing, they may become a reliable option for high-risk patients, suggesting potential effectiveness for treatments like TRAIPTA in the future. ^{1 2 3 4 5}

How is the TRAIPTA treatment for tricuspid regurgitation different from other treatments?

TRAIPTA is a transcatheter procedure, which means it is less invasive than traditional surgery and is designed for patients who are at high risk for surgical complications. This approach offers a lower-risk alternative to manage tricuspid regurgitation, which is often challenging to treat with standard surgical methods. ^{2 6 7 8 9}

What is the purpose of this trial?

Background: Tricuspid valve regurgitation is a disease where one of the heart valves leaks. The leak affects blood flow. People with this disease may feel breathless and lack energy; they may need to stay in the hospital when fluid builds up in the body. The tricuspid is the most difficult valve to repair with surgery. Researchers want to try a new procedure called trans-atrial intra-pericardial tricuspid annuloplasty (TRAIPTA). Objective: To test TRAIPTA in people with tricuspid valve regurgitation. Eligibility: Adults aged 21 years and over with tricuspid valve regurgitation. They must not be eligible for standard surgical repair. Design: Participants will be screened. They will have tests of their heart function; these will include blood tests, imaging scans, and a 6-minute walking test. Participants will enter the hospital for at least 1 day. The TRAIPTA procedure will be done under sedation or general anesthesia. The TRAIPTA study device is a loop that will be placed around the heart like a belt. It acts like a lasso to reduce leakage of the heart valve. Doctors will put the device in place by inserting a wire through a vein in the leg; they will thread the device up to the heart through the vein. The wire will be removed, but the TRAIPTA device will remain in place. Participants will have follow-up visits 4 times in 1 year after the procedure. These visits will include physical exams, blood tests, imaging scans, and other tests of heart function. Researchers will contact participants or their doctors for heart test results for another 4 years....

Research Team

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

This trial is for adults over 21 with tricuspid valve regurgitation who can't have standard surgery. They'll undergo screening tests, including heart function assessments, before the procedure.

Inclusion Criteria

Cardiac size suitable for available TRAIPTA study devices according to NHLBI Core Lab analysis of cardiac CTA indicating a TRAIPTA extracardiac perimeter of 25-40cm

Concordance of the study central clinical eligibility committee

I am 21 years old or older.

Exclusion Criteria

My heart's left ventricle is weak, with an ejection fraction less than 30%.

Known hypersensitivity to study device materials (for example, nickel)

Pregnancy or intent to become pregnant prior to completion of all 12-month protocol follow-up procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo the TRAIPTA procedure, which involves placing a device around the heart to reduce valve leakage

1 day

Hospital stay for at least 1 day

Follow-up

Participants have follow-up visits to monitor safety and effectiveness, including physical exams, blood tests, and imaging scans

1 year

4 visits (in-person)

Long-term follow-up

Researchers contact participants or their doctors for heart test results to monitor long-term safety and effectiveness

4 years

Treatment Details

Interventions

• TRAIPTA

Trial Overview The TRAIPTA procedure is being tested to reduce leakage in the tricuspid heart valve. It involves placing a loop device around the heart via a vein in the leg while under sedation or anesthesia.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Findings from Research

The PASCAL transcatheter valve repair system showed low complication rates and high survival rates in treating severe tricuspid regurgitation, with only 3.1% cardiovascular mortality at 30 days and 87.9% freedom from all-cause mortality at 1 year among 65 patients studied.

Significant improvements were observed in TR severity, functional status, and quality of life, with 86% of patients achieving moderate or less TR and a notable increase in walking distance and overall health scores after 1 year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1-Year Outcomes of Transcatheter Tricuspid Valve Repair. Kodali, SK., Hahn, RT., Davidson, CJ., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

TRI-SCORE and benefit of intervention in patients with severe tricuspid regurgitation. [2023]

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

1-Year Outcomes of Transcatheter Tricuspid Valve Repair. [2023]

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

Evolution of tricuspid regurgitation after mitral valve surgery for patients with moderate-or-less functional tricuspid regurgitation. [2012]

4. Germany pubmed.ncbi.nlm.nih.gov

Management of tricuspid valve regurgitation: Position statement of the European Society of Cardiology Working Groups of Cardiovascular Surgery and Valvular Heart Disease. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Tricuspid valve surgery for functional tricuspid valve regurgitation associated with left-sided valvular disease. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Comparison of transcatheter leaflet-approximation and direct annuloplasty in tricuspid regurgitation. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical and Echocardiographic Outcomes of Transcatheter Tricuspid Valve Interventions: A Systematic Review and Meta-Analysis. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Novel treatment of atrial functional tricuspid regurgitation using transcatheter bicaval valve implantation (TricValve). [2022]

9. France pubmed.ncbi.nlm.nih.gov

Transcatheter treatment of tricuspid regurgitation (focusing on current technologies). [2019]