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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
Must not have
Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
Carcinoid tricuspid regurgitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 30 days post-procedure
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have stents or an IVC filter that might interfere with certain medical procedures.
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I have a heart valve issue due to carcinoid syndrome.
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I have a heart condition that hasn't been treated but needs surgery.
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I need surgery urgently.
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My heart's valve size is suitable for Intrepid TTVR.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 30 days post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 30 days post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of implant or delivery related serious adverse events
Secondary study objectives
Change in NYHA Class from baseline
Change in TR Grade from baseline
Rate of no significant TV stenosis
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
36,158 Total Patients Enrolled

Media Library

Intrepid TTVR System (Bioprosthetic Valve) Clinical Trial Eligibility Overview. Trial Name: NCT04433065 — N/A
Tricuspid Regurgitation Research Study Groups: Primary Cohort
Tricuspid Regurgitation Clinical Trial 2023: Intrepid TTVR System Highlights & Side Effects. Trial Name: NCT04433065 — N/A
Intrepid TTVR System (Bioprosthetic Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04433065 — N/A
~2 spots leftby Jul 2025
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