Edwards EVOQUE System for Tricuspid Valve Disease

Not currently recruiting at 64 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a new tricuspid valve replacement system called the Edwards EVOQUE System. It aims to assist individuals with severe tricuspid regurgitation, a condition where the heart valve fails to close properly, causing blood to flow backward. Participants may receive the new valve system along with standard medical therapy or continue with medical therapy alone. This trial suits those who have experienced symptoms of tricuspid regurgitation despite treatment and have been hospitalized for related heart failure. As an unphased trial, it provides an opportunity to contribute to medical research and potentially benefit from innovative treatment options.

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.

What prior data suggests that the Edwards EVOQUE System is safe for tricuspid valve disease?

Research has shown that the Edwards EVOQUE System, used for treating tricuspid valve problems, is generally safe. One study examined its effects on patients with severe tricuspid regurgitation, a condition where the heart valve leaks, and found encouraging safety results. Most patients experienced significant improvement, and the risks were low.

Specifically, there were few serious complications, such as heart failure or death, within the first 30 days. By one year, over 70% of patients had no more valve leakage. This suggests the treatment is well-tolerated, although, like any procedure, there are still risks.

The EVOQUE System is also being tested in real-world situations, where it continues to show positive safety results. Overall, these findings suggest the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Edwards EVOQUE System because it offers a minimally invasive option for replacing the tricuspid valve in patients with tricuspid regurgitation who aren't suitable for surgery. Unlike traditional surgical repair or replacement, this system is delivered via a catheter, reducing recovery time and risk associated with open-heart surgery. This approach provides hope for patients who might not have had viable treatment options before, potentially improving quality of life and outcomes by directly addressing the faulty valve with a less invasive method.

What evidence suggests that the Edwards EVOQUE System is effective for tricuspid valve disease?

Research has shown that the Edwards EVOQUE System effectively reduces tricuspid regurgitation—where blood flows backward through the heart's tricuspid valve—to mild or less in over 95% of patients. Studies have found that patients using this system experience significant improvement in symptoms and daily activities. In this trial, some participants will receive the Edwards EVOQUE System along with optimal medical therapy (OMT), while others will receive OMT alone. In real-world use, the EVOQUE System has proven safe and effective for those with severe tricuspid regurgitation. This treatment is specifically designed for patients with severe symptoms who may not be candidates for other types of surgery. Overall, the EVOQUE System shows promise for improving health and quality of life in those affected. ^{3 5 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2401918

Transcatheter Valve Replacement in Severe Tricuspid ... Transcatheter tricuspid-valve replacement reduces tricuspid regurgitation to a level that is deemed to be mild or less in more than 95% of patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879825016176

Early Outcomes of Real-World Transcatheter Tricuspid ... The aim of this study was to investigate the real-world safety and efficacy of the EVOQUE TTVR system in patients with severe TR treated at 12 ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2024.10.067

1-Year Results From TRISCEND II Pivotal Trial Treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality ...

4. edwards.com edwards.com/healthcare-professionals/products-services/transcatheter-mitral-tricuspid-technologies/evoque-tricuspid-valve-replacement-system

EVOQUE Tricuspid Valve Replacement System The EVOQUE tricuspid valve replacement system is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation.

5. businesswire.com businesswire.com/news/home/20251027759798/en/Successful-Patient-Outcomes-Demonstrated-With-Edwards-SAPIEN-M3-and-EVOQUE-Systems-New-Data-Presented-at-TCT-2025

Successful Patient Outcomes Demonstrated With Edwards' ... “These ENCIRCLE trial data demonstrate the near elimination of significant mitral regurgitation, drastically improved quality-of-life, and a ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230013B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Edwards EVOQUE Tricuspid Valve Replacement System (EVOQUE system) is indicated for the improvement of health status in patients with ...

7. 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 ...

8. edwards.com edwards.com/gb/healthcare-professionals/evoque-patient-outcomes

EVOQUE Patient Outcomes With the EVOQUE transcatheter tricuspid valve replacement (TTVR) system, you may help tricuspid regurgitation (TR) patients return to a life they love.3. >20%.