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TTVR Early Feasibility Study

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ClinicalTrials.gov Identifier: NCT04433065
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : November 22, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: Intrepid™ TTVR System Not Applicable

Detailed Description:
Multi-center, prospective, non-randomized, investigational, and pre-market.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : April 28, 2023
Estimated Study Completion Date : November 15, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Primary Cohort
Device: Intrepid TTVR System
 Device: Intrepid™ TTVR System
Device: Intrepid™ TTVR System


Outcome Measures
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Primary Outcome Measures :
  1. Rate of implant or delivery related serious adverse events [ Time Frame: Through 30 days post-procedure ]
    Rate of implant or delivery related serious adverse events


Secondary Outcome Measures :
  1. Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC) [ Time Frame: 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)

  2. Change in TR Grade from baseline [ Time Frame: Through 30 days post-procedure ]
    Change in TR Grade from baseline

  3. Rate of no significant TV stenosis [ Time Frame: Through 30 days post-procedure ]
    Rate of no significant TV stenosis

  4. Change in NYHA Class from baseline [ Time Frame: Through 30 days post-procedure ]
    Change in NYHA Class from baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433065


Contacts
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Contact: Sarah Brown 7075917775 rs.tmvrtransfemoralefs@medtronic.com
Contact: Lynnett Stahl rs.tmvrtransfemoralefs@medtronic.com

Locations
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United States, Alabama
University of Alabama at Birmingham (UAB) Hospital Recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: Mustafa Ahmed, MD         
United States, Arizona
Abrazo Arizona Heart Hospital Recruiting
Phoenix, Arizona, United States, 85016
Principal Investigator: Timothy Byrne, MD         
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Khaled Alsabaawi       khaled.alsabaawi@cshs.org   
Principal Investigator: Raj Makkar         
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Christian Spies, MD         
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: Adam Greenbaum, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jessica Oakley         
Principal Investigator: Stanley Chetcuti, MD         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Principal Investigator: Paul Sorajja, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Azeem Latib, MD         
Columbia University Medical Center/NYPH Recruiting
New York, New York, United States, 10032
Principal Investigator: Susheel Kodali, MD         
United States, Ohio
OhioHealth Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Principal Investigator: Steven Yakubov, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Firas Zahr, MD         
United States, Pennsylvania
UPMC Pinnacle Harrisburg Campus Recruiting
Harrisburg, Pennsylvania, United States, 17101
Principal Investigator: Hemal Gada, MD         
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sachin Goel, MD         
United States, Wisconsin
Aurora St. Lukes Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53125
Contact: Jodi Kresa         
Principal Investigator: Tanvir Bajwa, MD         
Principal Investigator: Eric Weiss, MD         
Sponsors and Collaborators
Medtronic Cardiovascular
More Information
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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT04433065    
Other Study ID Numbers: MDT20009TMV003
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases