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Early Feasibility Study of the Intrepid™ TTVR System for Tricuspid Regurgitation

This study is testing a new device called the Intrepid™ TTVR System. This system is designed to replace your tricuspid valve (a heart valve) using a less invasive procedure through a vein in your leg (transfemoral access). You might be able to join if you are an adult (18 years or older) with severe tricuspid regurgitation (a condition where your tricuspid heart valve doesn't close properly, causing blood to flow backward) and your heart team believes you are too high-risk for traditional surgery. The main goal of this study is to see how safe the Intrepid™ TTVR System is by tracking any serious problems related to the implant or delivery of the device for 30 days after the procedure. The current recruitment status is unclear, and the study plans to enroll 150 participants.

Study design
This is a multi-center, prospective, non-randomized study that plans to enroll 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through 30 days post-procedure to monitor for serious adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04433065

TTVR Early Feasibility Study

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Medtronic Cardiovascular
~150 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:Intrepid™ TTVR System

At a glance

Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of implant or delivery related serious adverse events
Measured over Through 30 days post-procedure

Conditions

Tricuspid Regurgitation

Explore related trials

Tricuspid Valve Insufficiency

NCT04433065

Where you'd take part

This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott Northwestern Hospital

    Minneapolis, Minnesotano site contact published

  • Abrazo Arizona Heart Hospital

    Phoenix, Arizonano site contact published

  • Aurora Saint Lukes Medical Center

    Milwaukee, Wisconsinno site contact published

  • California Pacific Medical Center

    San Francisco, Californiano site contact published

  • Cedars Sinai Medical Center

    Los Angeles, Californiano site contact published

  • Corewell Health

    Grand Rapids, Michiganno site contact published

  • Emory University Hospital Midtown

    Atlanta, Georgiano site contact published

  • Hartford Hospital

    Hartford, Connecticutno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
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
Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Exclusion

Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
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
Echocardiographic evidence of severe right ventricular dysfunction
Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure
Need for emergent or urgent surgery
Untreated clinically significant coronary artery disease requiring revascularization
Carcinoid tricuspid regurgitation

What this trial measures

  • Rate of implant or delivery related serious adverse eventsThrough 30 days post-procedure

    Rate of implant or delivery related serious adverse events