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Bioprosthetic Valve
Tricuspid Valve Replacement for Tricuspid Regurgitation
N/A
Recruiting
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with severe symptomatic primary and/or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
New York Heart Association (NYHA) Function Class II or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 30 days post-procedure
Awards & highlights
Study Summary
This trial is testing a new, less invasive way to replace a failing tricuspid valve.
Who is the study for?
This trial is for people with moderate to severe heart valve disease (tricuspid regurgitation) who are still symptomatic despite medication. Candidates must be suitable for the Intrepid TTVR system and able to undergo a procedure through the thigh vein. They should commit to follow-up visits, have an acceptable risk level for valve surgery as assessed by their medical team, and not expect any non-heart related health issues to limit their life span under two years.Check my eligibility
What is being tested?
The study tests the Intrepid transcatheter tricuspid valve replacement (TTVR) system's performance in replacing the heart's tricuspid valve via a leg vein without open-heart surgery. It aims to provide early clinical insights into how well this minimally invasive approach works.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may include risks like bleeding, infection at the access site, irregular heartbeats, or damage to nearby blood vessels or organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe heart valve issues confirmed by heart scans.
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My heart condition limits my physical activity.
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My body is suitable for a specific heart valve procedure through the leg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 30 days post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 30 days post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of implant or delivery related serious adverse events
Secondary outcome measures
Change in NYHA Class from baseline
Change in TR Grade from baseline
Rate of no significant TV stenosis
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Primary CohortExperimental Treatment1 Intervention
Device: Intrepid TTVR System
Find a Location
Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
36,317 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stents or an IVC filter that might interfere with certain medical procedures.My doctors agree I need a new heart valve despite medication.I have severe heart valve issues confirmed by heart scans.Your heart's pumping ability, as measured by a special heart ultrasound, is less than 30%.I have a heart valve issue due to carcinoid syndrome.You have a condition where the right side of your heart is not working properly, as shown by an echocardiogram.My heart condition limits my physical activity.I have a heart condition that hasn't been treated but needs surgery.My body is suitable for a specific heart valve procedure through the leg.I am of legal age to make my own health decisions.I need surgery urgently.You are not expected to live for more than 2 years because of other health problems not related to the heart.My heart's valve size is suitable for Intrepid TTVR.There is a mass or blood clot in your heart, large vein, or leg vein.The doctor's team thinks that the subject has a high chance of not surviving the tricuspid valve surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Cohort
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.
To what extent is enrollment in this research endeavor being facilitated?
"To begin the study, 15 eligible participants are necessary. Medtronic Cardiovascular will be managing the experiment from a variety of locations, such as Aurora Saint Luke's Medical in Milwaukee and Abrazo Arizona Heart Hospital in Phoenix."
Answered by AI
Are there any available openings for participants in this clinical exploration?
"Affirmative. According to the information found on clinicaltrials.gov, this trial was first made available on October 20th 2020 and has been actively recruiting since then; as of November 21st 2022 it is still looking for 15 participants from 15 different locations."
Answered by AI
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