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Prosthetic Valve

Cardiovalve System for Tricuspid Regurgitation

N/A
Waitlist Available
Research Sponsored by Boston Biomedical Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant distance of 6 minute walk test (6MWT) ≥ 60 m
Acceptable by the site "Heart Team" including an interventional cardiologist, cardiothoracic surgeon, heart failure cardiologist and recommended as a candidate for the Cardiovalve System
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 3 months, 6 months
Awards & highlights

Study Summary

This trial is testing a new device and delivery system for replacing the tricuspid valve. The safety and performance of the device will be monitored over 30 days and then for 5 years.

Who is the study for?
This trial is for adults aged 18-85 with severe, symptomatic tricuspid regurgitation who've been treated for related heart conditions. They must be able to walk at least 60 meters and have a left ventricular ejection fraction of ≥35%. Exclusions include significant coronary artery disease, prior valve surgeries, recent strokes, active infections or planned procedures within the next month.Check my eligibility
What is being tested?
The Cardiovalve Transfemoral System is being tested in this study to replace the tricuspid valve without open-heart surgery. The trial will assess safety and performance after 30 days and monitor patients' health over five years.See study design
What are the potential side effects?
Potential side effects may include complications from the procedure like bleeding or infection, adverse reactions to materials in the device or medications used during implantation, irregular heart rhythms, or issues with valve function post-operation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk 60 meters or more in 6 minutes.
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The heart team at the site has approved me as a candidate for the Cardiovalve system.
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I have severe heart valve leakage as confirmed by an ultrasound.
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My heart condition limits my physical activity but I can still perform light tasks.
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I am between 18 and 85 years old.
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I have been treated for heart issues according to guidelines for at least 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant
Primary Performance Endpoint - Clinical Performance - Reduction in Tricuspid Regurgitation severity measured using Echocardiography and compared to baseline
Primary Safety Endpoint (Patient Based) Participants Implanted without Major Device Related Adverse Events through thirty days
Secondary outcome measures
Secondary Performance Endpoint - 6 minute walk test
Secondary Performance Endpoint - Cusp Insufficiency
Secondary Performance Endpoint - Kansas City Cardiomyopathy Questionnaire
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cardiovalve Transfemoral Tricuspid ValveExperimental Treatment1 Intervention
Replacement (Implant) delivered through a transfemoral access

Find a Location

Who is running the clinical trial?

Boston Biomedical AssociatesLead Sponsor
8 Previous Clinical Trials
350 Total Patients Enrolled
Cardiovalve Ltd.Industry Sponsor
5 Previous Clinical Trials
155 Total Patients Enrolled
Cardiovascular Research Foundation, New YorkOTHER
24 Previous Clinical Trials
26,732 Total Patients Enrolled

Media Library

Cardiovalve Transfemoral System (Prosthetic Valve) Clinical Trial Eligibility Overview. Trial Name: NCT04100720 — N/A
Tricuspid Regurgitation Research Study Groups: Cardiovalve Transfemoral Tricuspid Valve
Tricuspid Regurgitation Clinical Trial 2023: Cardiovalve Transfemoral System Highlights & Side Effects. Trial Name: NCT04100720 — N/A
Cardiovalve Transfemoral System (Prosthetic Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04100720 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I satisfy the qualifications to participate in this medical experiment?

"This clinical trial is seeking 15 candidates suffering from tricuspid valve insufficiency, with an age range of 18 years to 84. To be considered a viable candidate they must have been adequately treated under medical standards for at least one calendar month prior to the procedure and receive approval by both the site's "Heart Team" as well as the Subject Screening Committee."

Answered by AI

Are elderly individuals over 85 years partaking in this medical study?

"As stated by the study's requirements, individuals must be between 18 and 84 years old to qualify for enrolment."

Answered by AI

What is the purpose of this investigation?

"This 30-day study will evaluate the technical success of cardiovalve delivery, unrestricted movement of cusps, tricuspid regurgitation severity (using a 0 to 4+ scale) and change in degree of cusp insufficiency."

Answered by AI

Are there any active recruitment initiatives for this clinical trial?

"Per the data hosted on clinicaltrials.gov, this medical trial has ceased search for participants. Initially posted in October of 2022 and last edited in July 2021, there are nevertheless 40 other trials that require enrolment currently active."

Answered by AI
~10 spots leftby Dec 2025