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Tricuspid Valve Replacement System
Edwards EVOQUE System for Tricuspid Valve Disease
N/A
Recruiting
Led By James Gammie, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TR graded as severe or greater
Symptomatic tricuspid regurgitation (TR) despite medical therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test how safe and effective the Edwards EVOQUE tricuspid valve replacement system is.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include complications related to catheter insertion such as bleeding or infection, adverse reactions to materials in the device, irregular heartbeat patterns (arrhythmias), and possible deterioration of the new valve function over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is considered severe or worse.
Select...
I have symptoms from a leaky tricuspid heart valve despite taking medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement
Rate of Major Adverse Events (MAE)
TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
Secondary outcome measures
Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Single-Arm RegistryExperimental Treatment1 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 & OMTExperimental Treatment1 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 StudyExperimental Treatment1 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 Control1 Intervention
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
60,504 Total Patients Enrolled
1 Trials studying Tricuspid Valve Disease
870 Patients Enrolled for Tricuspid Valve Disease
James Gammie, MDPrincipal InvestigatorJohns Hopkins Health System
1 Previous Clinical Trials
144 Total Patients Enrolled
Susheel Kodali, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
2,515 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's tricuspid valve has a physical issue preventing certain treatments.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 don't need urgent surgery or any heart surgery in the next year.I have symptoms from a leaky tricuspid heart valve despite taking medication.My heart failure needs advanced treatment.My blood pressure and heart rate are stable.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Single-Arm Registry
- Group 2: Continued Access Study
- Group 3: Edwards EVOQUE System & OMT
- Group 4: Optimal Medical Therapy (OMT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare centers are administrating this trial?
"Additional clinical trial sites include the State University of New york at Buffalo in Buffalo, Medical Center of the Rockies in Loveland, and North Shore University Hospital located in Manhasset. Altogether there are 49 locations running this medical study."
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