Clinical trial NCT04433065: TTVR Early Feasibility Study
Official title: The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Multi-center, prospective, non-randomized, investigational, and pre-market.

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

Primary outcomes:
measure: Rate of implant or delivery related serious adverse events
timeFrame: Through 30 days post-procedure
Secondary outcomes:
measure: Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
timeFrame: During Procedure
measure: Change in TR Grade from baseline
timeFrame: Through 30 days post-procedure
measure: Rate of no significant TV stenosis
timeFrame: Through 30 days post-procedure
measure: Change in NYHA Class from baseline
timeFrame: Through 30 days post-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) Hospital
state: Alabama
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Missoula
country: United States
facility: Providence Saint Patrick Hospital
state: Montana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Harrisburg
country: United States
facility: UPMC Pinnacle Harrisburg Campus
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Milwaukee
country: United States
facility: Aurora St. Lukes Medical Center
state: Wisconsin
Study officials:
References: