TTVR Early Feasibility Study

The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System

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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Intrepid™ TTVR System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Brown; Phone Number: 7075917775; Email: rs.tmvrtransfemoralefs@medtronic.com
• Study Contact Backup: Name: Lynnett Stahl; Email: rs.tmvrtransfemoralefs@medtronic.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham (UAB) Hospital
      • Principal Investigator: Mustafa Ahmed, MD
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Abrazo Arizona Heart Hospital
      • Principal Investigator: Timothy Byrne, MD
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
      • Principal Investigator: Raj Makkar
      • Contact: Khaled Alsabaawi; Email: khaled.alsabaawi@cshs.org
    • San Francisco, California, United States, 94115
      • Recruiting
      • California Pacific Medical Center
      • Principal Investigator: Christian Spies, MD
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
      • Principal Investigator: Adam Greenbaum, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Jessica Oakley
      • Principal Investigator: Stanley Chetcuti, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Abbott Northwestern Hospital
      • Principal Investigator: Paul Sorajja, MD
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Principal Investigator: Azeem Latib, MD
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center/NYPH
      • Principal Investigator: Susheel Kodali, MD
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • OhioHealth Riverside Methodist Hospital
      • Principal Investigator: Steven Yakubov, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Principal Investigator: Firas Zahr, MD
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • Recruiting
      • UPMC Pinnacle Harrisburg Campus
      • Principal Investigator: Hemal Gada, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Principal Investigator: Sachin Goel, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53125
      • Recruiting
      • Aurora St. Lukes Medical Center
      • Contact: Jodi Kresa
      • Principal Investigator: Tanvir Bajwa, MD
      • Principal Investigator: Eric Weiss, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Cohort; Device: Intrepid TTVR System	Device: Intrepid™ TTVR System; Device: Intrepid™ TTVR System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of implant or delivery related serious adverse events	Rate of implant or delivery related serious adverse events	Through 30 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	During Procedure
Change in TR Grade from baseline	Change in TR Grade from baseline	Through 30 days post-procedure
Rate of no significant TV stenosis	Rate of no significant TV stenosis	Through 30 days post-procedure
Change in NYHA Class from baseline	Change in NYHA Class from baseline	Through 30 days post-procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): April 30, 2031

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: MDT20009TMV003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes