Tricuspid Valve Repair for Tricuspid Regurgitation

Not currently recruiting at 80 trial locations

Overseen By Natalie Richardson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must be taking: Diuretics

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pulmonary hypertension, Hypertension, Valve procedure, others

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

Compensation: Varies

Number of Visits: 1

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment option for individuals with severe tricuspid regurgitation, a heart valve issue where blood flows backward into the heart. It compares the TriClip device, a small implant that aids the tricuspid valve in closing more effectively, to standard medical treatment. The trial aims to determine if the TriClip device is safe and effective in improving symptoms for those who cannot undergo regular surgery due to high risk. Individuals who continue to experience symptoms despite treatment and are considered high-risk for surgery might be suitable candidates. As an unphased trial, this study provides patients the chance to explore innovative treatment options that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on optimized medical therapy for tricuspid regurgitation and other related conditions, so you may need to continue certain treatments.

What prior data suggests that the TriClip device is safe for tricuspid regurgitation?

Research has shown that the TriClip device is generally safe for people. In one study, 98.9% of patients did not experience major health problems related to the treatment within 30 days, indicating that most patients did not have serious side effects soon after using TriClip.

Another study confirmed these findings, demonstrating that the TriClip was safe and effective over three years. Patients continued to see improvements without major safety issues, indicating that the device remains safe over a longer period.

Overall, the TriClip device is well-tolerated, with only a very small number of patients experiencing issues. This makes it a promising option for those with severe tricuspid regurgitation, a condition where the heart valve leaks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TriClip device for tricuspid regurgitation because it offers a minimally invasive solution, unlike traditional surgical options. While standard treatments often involve open-heart surgery, the TriClip is delivered via a catheter, which means no large incisions and potentially faster recovery times. Additionally, the device specifically targets the tricuspid valve to improve its function, which can lead to better outcomes for patients with this condition. This innovative approach could transform the way tricuspid regurgitation is managed, providing a less risky and more patient-friendly alternative to surgery.

What evidence suggests that the TriClip device is effective for tricuspid regurgitation?

Research has shown that the TriClip device is safe and effective for treating severe tricuspid regurgitation (TR), a heart valve problem. In this trial, some participants will receive the TriClip device, which studies have found significantly reduces TR and helps patients walk longer distances in six minutes. After one year, patients experienced fewer hospital visits due to heart failure and reported improved quality of life. These benefits have persisted for up to three years in some studies. Overall, the TriClip device presents a promising treatment option for individuals with severe TR. ^{2 3 5 6 7}

Who Is on the Research Team?

Meghan Griffin, PhD

Principal Investigator

Abbott Structural Heart

David Adams, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Paul Sorajja, MD

Principal Investigator

Allina Health System

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe tricuspid regurgitation (TR), a heart valve disease, who are too high-risk for surgery. They must have stable symptoms despite treatment and be in NYHA Functional Class II-IV. Participants need suitable veins for the device and can't join if they have certain heart conditions, uncontrolled blood pressure, recent heart attacks or strokes, active infections or ulcers, allergies to the device materials or necessary medications, other serious health issues that could affect participation or life expectancy under one year.

Inclusion Criteria

Doctors can use a large catheter in my leg vein.

My heart condition limits my physical activity but I can still take care of myself.

Subject must provide written informed consent prior to any trial related procedure

Exclusion Criteria

Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Your heart has high blood pressure in the arteries connected to your lungs.

Your tricuspid valve cannot be properly checked using certain heart imaging tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TriClip device or continue with medical therapy

30 days

1 visit (in-person) for device implantation, followed by regular medical therapy visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits to assess quality of life and adverse events

Long-term Follow-up

Participants are monitored for long-term outcomes such as recurrent heart failure hospitalizations and survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

• TriClip device

Trial Overview The TRILUMINATE Pivotal Trial is testing the safety and effectiveness of the TriClip device compared to standard medical therapy in improving outcomes for patients with severe TR. The TriClip is an investigational device designed to repair the tricuspid valve without needing open-heart surgery.

How Is the Trial Designed?

Group I: Single Arm Group Experimental Treatment 1 Intervention

Subjects will receive the TriClip device and will continue to be managed on medical therapy, per physician discretion.

Group II: Randomized - Device Group Experimental Treatment 1 Intervention

Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion

Group III: Continued Access Study (CAS) Experimental Treatment 1 Intervention

Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion

Group IV: Randomized - Control Group Active Control 1 Intervention

Subjects will continue to be managed on medical therapy, per physician discretion

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Published Research Related to This Trial

Transcatheter edge-to-edge repair techniques, like the TriClip and PASCAL Implant System, have been shown to be safe and effective for treating significant tricuspid regurgitation in older patients who are at high surgical risk.

These devices have received CE mark approval based on clinical trials demonstrating their feasibility and efficacy, but further randomized controlled trials are needed to fully assess their impact compared to standard treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Leaflet Strategies for Tricuspid Regurgitation TriClip and CLASP. Vogelhuber, J., Weber, M., Nickenig, G.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39471883/

1-Year Outcomes From the TRILUMINATE Randomized ... TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in 6-minute walk distance ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879824008513

3-Year Outcomes From the TRILUMINATE Study The TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic ...

3. tctmd.com tctmd.com/news/more-data-tricuspid-valve-interventions-reassure-yet-questions-remain

More Data on Tricuspid Valve Interventions Reassure, yet ... “TriClip is very safe and effective with a significant improvement in quality of life at 30 days with very low rates of mortality, heart failure ...

4. structuralheart.abbott structuralheart.abbott/int/products/transcatheter-tricuspid-valve-repair/triclip-tmvr-clinical-data

Triclip Tricuspid Valve Repair (TEER) Clinical Data Proven safety and effectiveness. The TRILUMINATE™ Trial demonstrated that TriClip TEER safely and effectively reduces TR and HF hospitalizations.

5. jacc.org jacc.org/doi/10.1016/j.jacc.2024.05.006

Real-World 1-Year Results of Tricuspid Edge-to ... Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse, real-world ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230007B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Tricuspid Valve Repair Device ... valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity.

7. abbott.mediaroom.com abbott.mediaroom.com/2025-03-31-New-Late-Breaking-Data-Reinforce-Benefits-of-Abbotts-TriClip-TM-for-People-With-Leaky-Tricuspid-Heart-Valve

New Late-Breaking Data Reinforce Benefits of Abbott's TriClip ... Patients in the crossover group achieved similar improvements in KCCQ score (+13 points on average) once implanted with TriClip. "With the ...