Tricuspid Valve Repair for Tricuspid Regurgitation

Recruiting at 76 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

572 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device called TriClip that helps fix a leaky heart valve without major surgery. It is for patients with severe valve issues who are at high risk from traditional surgery. The device clips the valve flaps together to reduce leakage and improve heart function. This procedure is less invasive and more cost-effective than medication treatment.

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 data supports the effectiveness of the TriClip treatment for tricuspid regurgitation?

The TriClip device, used for tricuspid edge-to-edge repair, has been quickly adopted after its approval, indicating its potential effectiveness in treating tricuspid regurgitation. This suggests that it may be a promising option for patients with this condition. ^{1 2 3 4 5}

Is the TriClip device safe for tricuspid valve repair?

The TriClip device has been evaluated in several clinical trials and is considered safe and feasible for tricuspid valve repair, with promising results in reducing valve regurgitation. However, there are rare cases of the device dislocating, which can be managed without surgery. ^{6 7 8 9 10}

How does the TriClip treatment for tricuspid regurgitation differ from other treatments?

The TriClip treatment is unique because it is a minimally invasive procedure that uses a transcatheter approach to repair the tricuspid valve, making it a safer option for patients who are at high risk for traditional surgery. It involves the use of a device similar to the MitraClip, which has been adapted specifically for the tricuspid valve, offering a promising alternative for those with severe tricuspid regurgitation. ^{6 7 8 11 12}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transcatheter Tricuspid Valve Replacement: Principles and Design. [2020]

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

Custom Triflange Cups: 20-Year Experience. [2021]

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

Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-to-edge Repair: Observations from the bRIGHT TriClip™ Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The custom triflange cup: build it and they will come. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Surgical treatment of traumatic tricuspid insufficiency: experience in 13 cases. [2016]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter Leaflet Strategies for Tricuspid Regurgitation TriClip and CLASP. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Tricuspid Clip: Step-by-Step and Clinical Data. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[MitraClip® for treatment of tricuspid valve insufficiency]. [2018]

10. England pubmed.ncbi.nlm.nih.gov

How to remove an embolized TriClip from the femoral vein? A case report. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Contemporary review of percutaneous therapy for tricuspid valve regurgitation. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Update on the Current Landscape of Transcatheter Options for Tricuspid Regurgitation Treatment. [2020]