| NCT ID | NCT04433065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Cardiovascular |
| Condition | Tricuspid Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2020-10-20 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2020-10-20 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04433065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04433065 currently recruiting?
Yes, NCT04433065 is actively recruiting participants. Contact the research team at rs.tricuspidclinical@medtronic.com for enrollment information.
Where is the NCT04433065 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Los Angeles, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT04433065 clinical trial?
NCT04433065 is sponsored by Medtronic Cardiovascular. The trial plans to enroll 150 participants.