TRAIPTA Procedure for Tricuspid Regurgitation

Recruiting at 4 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called TRAIPTA to assist individuals with tricuspid valve regurgitation, a condition where a heart valve leaks and disrupts blood flow. The innovative TRAIPTA procedure places a loop around the heart to reduce valve leakage, potentially improving symptoms like breathlessness and low energy. It targets individuals with severe valve leakage who are not eligible for standard surgery. Suitable candidates are adults with severe symptoms affecting daily life who have not received traditional surgical repairs. Participants will undergo regular follow-ups for up to a year to monitor the procedure's effectiveness and safety. As an unphased trial, this study provides patients access to cutting-edge treatment options not yet widely available.

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 the TRAIPTA procedure is safe for tricuspid valve regurgitation?

Research has shown that the TRAIPTA procedure is designed to be safe and effective. Studies have demonstrated its safe application on animals like pigs, yielding consistent results. The procedure involves placing a device around a heart valve to reduce leakage and has been tested for its ability to reshape the valve effectively.

Although specific data on humans is not widely available yet, the procedure has been safely performed in controlled settings. The device is inserted through a vein in the leg, making it less invasive than traditional surgery. This approach aims to lower the risks associated with open-heart surgery. While potential risks exist with any new treatment, current findings are promising regarding its safety. Participants in this trial will receive close monitoring to ensure the procedure is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TRAIPTA procedure because it offers a new approach to treating tricuspid regurgitation, a condition that often relies on surgical repair or replacement of the tricuspid valve. Unlike standard treatments that are more invasive, TRAIPTA is a minimally invasive technique that involves Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty. This method targets the tricuspid valve directly through a less invasive path, potentially reducing recovery time and minimizing risks associated with open-heart surgery. This innovative approach could provide a safer and more efficient alternative for patients with tricuspid regurgitation.

What evidence suggests that the TRAIPTA procedure is effective for tricuspid valve regurgitation?

Research suggests that TRAIPTA, the treatment under study in this trial, could aid individuals with tricuspid valve regurgitation by reducing the leak in the heart valve. In earlier studies, this technique successfully reshaped the valve, improving the connection of the valve flaps (the parts that open and close) by 53%. This enhancement helps the valve function better and allows blood to flow more smoothly. Early results from some animal studies indicate that TRAIPTA can decrease the severity of valve leakage. While these findings are promising, more research in humans is needed to fully understand its effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06479824

NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid ... The objectives of this study are to test whether TRAIPTA is feasible, safe, favorably remodels tricuspid annular geometry, and reduces severity of functional ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25703872/

Transatrial intrapericardial tricuspid annuloplasty - PubMed Tricuspid leaflet coaptation length was increased by 53% (p < 0.001). Tricuspid geometric changes were maintained after 9.7 days (range, 7 to 14 days). Small ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0033062021001250

Transcatheter tricuspid valve interventions: Current devices ... Our first-in-human results of the transcatheter tricuspid annular reconstruction using the K-Clip™ system demonstrated initial favorable procedural success, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4524739/

Transatrial Intrapericardial Tricuspid Annuloplasty - PMC In animals with induced functional TR, we showed that TRAIPTA effectively reduces the severity of tricuspid regurgitation. We also explored the ...

5. cdt.amegroups.org cdt.amegroups.org/article/view/29448/28189

Current state of transcatheter tricuspid valve repair - Kolte Data from the TriValve Registry on 18 patients who underwent TV repair with the TriAlign system demonstrated procedural success rate of 69.2% and zero deaths at ...

6. jacc.org jacc.org/doi/10.1016/j.jacc.2013.08.858

TCT-127 Trans-Auricular Intra-Pericardial Tricuspid ... In naïve swine, trans-auricular pericardial access was easy and safe. The TRAIPTA device is consistently delivered to the AV groove, tension can ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0914508724000601

Transcatheter tricuspid valve interventions: Current devices ... Tricuspid transcatheter edge-to-edge repair (TEER) using TriClip was found to be safe with 98.3 % of patients who underwent the procedure free from major ...