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Transcatheter Valve Replacement
Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation
N/A
Waitlist Available
Led By Susheel Kodali, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic despite medical therapy or prior HF hospitalization from TR
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 6 months, 12 months, annual for five years
Awards & highlights
Study Summary
This trial is to test whether a new tricuspid valve replacement system is safe and works well.
Who is the study for?
This trial is for people with a heart condition called tricuspid regurgitation who still have symptoms despite medication or have been hospitalized for heart failure. They must be considered suitable for a non-surgical valve replacement by their medical team, and not in need of urgent surgery or other cardiac procedures within the next year.Check my eligibility
What is being tested?
The TRISCEND study is testing the safety and effectiveness of a new procedure called Transcatheter Tricuspid Valve Replacement using the Edwards EVOQUE system. It's done without open-heart surgery to see if it can help patients with tricuspid valve issues.See study design
What are the potential side effects?
Potential side effects may include bleeding, infection at the catheter insertion site, irregular heartbeats, kidney problems, stroke, or device-related complications like dislodgement or malfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I still have symptoms despite treatment, or I was hospitalized for heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days, 6 months, 12 months, annual for five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 6 months, 12 months, annual for five years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from device or procedure-related adverse events [Time Frame: 30 days]
Secondary outcome measures
Health Status - KCCQ
Health Status - SF-36
NYHA Functional Class
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,346 Total Patients Enrolled
Susheel Kodali, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
3,357 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.My blood pressure and heart rate are stable.I do not need any urgent surgery or have any planned heart surgery in the next year.My heart team has approved me for a specific heart valve replacement procedure.I still have symptoms despite treatment, or I was hospitalized for heart failure.You are currently taking part in another research study and have not completed the main goal of that study.My heart failure needs advanced treatment.You have a moderate or severe problem with your tricuspid valve.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the patient sample for this clinical research?
"Affirmative. According to clinicaltrials.gov, this trial is actively seeking participants as of July 11th 2022 after first being posted on May 6th 2020. The experiment requires 200 people from 3 different locations to participate."
Answered by AI
Are there any opportunities for recruitment in this research project?
"Correct. Details on clinicaltrials.gov demonstrate that this medical study, which had an initial posting date of May 6th 2020, is actively recruiting for 200 patients to be enrolled from 3 different sites."
Answered by AI
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