TTVR Early Feasibility Study
ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Cardiovascular
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Intrepid™ TTVR System
DeviceDevice: Intrepid™ TTVR System
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Primary CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of implant or delivery related serious adverse events
Rate of implant or delivery related serious adverse events
Time frame
Through 30 days post-procedureSecondary outcomes
1
Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions)
Time frame
During Procedure2
Change in TR Grade from baseline
Change in TR Grade from baseline
Time frame
Through 30 days post-procedure3
Rate of no significant TV stenosis
Rate of no significant TV stenosis
Time frame
Through 30 days post-procedure4
Change in NYHA Class from baseline
Change in NYHA Class from baseline
Time frame
Through 30 days post-procedureSponsors and contacts
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Source ClinicalTrials.gov