MedPath

TTVR Early Feasibility Study

Not Applicable
Recruiting
Conditions
Tricuspid Regurgitation
Interventions
Device: Intrepid™ TTVR System
Registration Number
NCT04433065
Lead Sponsor
Medtronic Cardiovascular
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Primary CohortIntrepid™ TTVR SystemDevice: Intrepid TTVR System
Primary Outcome Measures
NameTimeMethod
Rate of implant or delivery related serious adverse eventsThrough 30 days post-procedure

Rate of implant or delivery related serious adverse events

Secondary Outcome Measures
NameTimeMethod
Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)During Procedure

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)

Change in NYHA Class from baselineThrough 30 days post-procedure

Change in NYHA Class from baseline

Change in TR Grade from baselineThrough 30 days post-procedure

Change in TR Grade from baseline

Rate of no significant TV stenosisThrough 30 days post-procedure

Rate of no significant TV stenosis

Trial Locations

Locations (20)

University of Alabama at Birmingham (UAB) Hospital

🇺🇸

Birmingham, Alabama, United States

Abrazo Arizona Heart Hospital

🇺🇸

Phoenix, Arizona, United States

Cedars Sinai Medical Center

🇺🇸

Los Angeles, California, United States

California Pacific Medical Center

🇺🇸

San Francisco, California, United States

Hartford Hospital

🇺🇸

Hartford, Connecticut, United States

Emory University Hospital Midtown

🇺🇸

Atlanta, Georgia, United States

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

Corewell Health

🇺🇸

Grand Rapids, Michigan, United States

Abbott Northwestern Hospital

🇺🇸

Minneapolis, Minnesota, United States

Providence Saint Patrick Hospital

🇺🇸

Missoula, Montana, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

The Mount Sinai Hospital

🇺🇸

New York, New York, United States

Columbia University Medical Center/NYPH

🇺🇸

New York, New York, United States

The Christ Hospital

🇺🇸

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

🇺🇸

Cleveland, Ohio, United States

OhioHealth Riverside Methodist Hospital

🇺🇸

Columbus, Ohio, United States

Oregon Health & Science University

🇺🇸

Portland, Oregon, United States

UPMC Pinnacle Harrisburg Campus

🇺🇸

Harrisburg, Pennsylvania, United States

Houston Methodist Hospital

🇺🇸

Houston, Texas, United States

Aurora St. Lukes Medical Center

🇺🇸

Milwaukee, Wisconsin, United States

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