Edwards EVOQUE System for Tricuspid Valve Disease

Recruiting at 62 trial locations

Overseen By TMTT Clinical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Anatomic contraindications, Hemodynamic instability, others

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

Compensation: Varies

Number of Visits: 30

Duration: 6 months

1070 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Edwards EVOQUE system, which replaces a faulty heart valve. It targets patients with severe tricuspid regurgitation, a condition where the heart valve does not close properly. The new valve helps blood flow correctly through the heart, improving its function and reducing symptoms. The EVOQUE system has shown promise in initial studies for treating severe tricuspid regurgitation.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How is the Edwards EVOQUE System treatment different from other treatments for tricuspid valve disease?

The Edwards EVOQUE System is unique because it is a minimally invasive treatment that replaces the tricuspid valve through a catheter inserted in the leg (transfemoral approach), which is particularly beneficial for patients at high surgical risk. This approach is different from traditional open-heart surgery and offers a new option for those who may not be candidates for surgery. ^{1 2 3 4 5}

What data supports the effectiveness of the Edwards EVOQUE System treatment for tricuspid valve disease?

Research shows that the Edwards EVOQUE System, used for replacing the tricuspid valve, has been studied for its safety and effectiveness. In a study, patients with tricuspid regurgitation (a condition where the heart's tricuspid valve doesn't close tightly) showed positive outcomes one year after receiving the treatment, indicating its potential effectiveness. ^{1 3 4 6 7}

Research Team

Vinod Thourani, MD

Principal Investigator

Piedmont Heart Institute

Philipp Lurz, MD

Principal Investigator

Herzzentrum Leipzig GmbH

Susheel Kodali, MD

Principal Investigator

Columbia University

Rebecca Hahn, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for individuals with severe symptoms of tricuspid regurgitation who haven't improved with medical therapy. Candidates should be suitable for a non-surgical valve replacement as determined by their heart care team. People are excluded if they have certain tricuspid valve issues, need urgent heart surgery, are hemodynamically unstable, require advanced treatment for heart failure, or are in another study.

Inclusion Criteria

Your local heart team has determined that you are a good candidate for a transcatheter tricuspid valve replacement.

My condition is considered severe or worse.

I have symptoms from a leaky tricuspid heart valve despite taking medication.

Exclusion Criteria

My heart's tricuspid valve has a physical issue preventing certain treatments.

I don't need urgent surgery or any heart surgery in the next year.

My heart failure needs advanced treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy

6 months

Visits at discharge, 30 days, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits

Treatment Details

Interventions

• Edwards EVOQUE System
• Optimal Medical Therapy

Trial Overview The TRISCEND II Pivotal Trial is testing the safety and effectiveness of the Edwards EVOQUE system which replaces the tricuspid valve without needing open-heart surgery against Optimal Medical Therapy alone in managing heart valve disease.

Participant Groups

Group I: Single-Arm Registry Experimental Treatment 1 Intervention

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

Group II: Edwards EVOQUE System & OMT Experimental Treatment 1 Intervention

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation

Group III: Continued Access Study Experimental Treatment 1 Intervention

Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.

Group IV: Optimal Medical Therapy (OMT) Active Control 1 Intervention

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Findings from Research

In a review of 6 studies involving 1,664 patients, both the Edwards SAPIEN S3 (ES3) and Medtronic's Evolut R transcatheter heart valves showed similar safety profiles and procedural success rates, with no significant differences in 30-day mortality, stroke, or major complications.

However, the ES3 group had a higher risk of acute kidney injury, while the Evolut R group had a higher rate of new permanent pacemaker implantation, indicating different safety considerations for each device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis. Li, YM., Tsauo, JY., Liao, YB., et al.[2021]

The Edwards INTUITY Valve System demonstrated excellent safety and efficacy in a study of 500 patients with severe aortic stenosis, showing a low 30-day mortality rate of 0.8% and high overall survival rates of 94%, 89%, and 81% at 1, 3, and 5 years, respectively.

The valve exhibited good hemodynamic performance with mean gradients remaining stable over 5 years, although there was a notable 8.6% rate of new pacemaker implantation, indicating a need for careful monitoring post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†. Andreas, M., Coti, I., Rosenhek, R., et al.[2020]

References

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

Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience. [2022]

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

Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience. [2021]

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

Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis. [2021]

5. China pubmed.ncbi.nlm.nih.gov

Outcome of rapid deployment aortic valves: long-term experience after 700 implants. [2022]

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

Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†. [2020]

7. France pubmed.ncbi.nlm.nih.gov

Percutaneous Edwards SAPIEN valve implantation in the tricuspid position: case report and review of literature. [2012]