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TTVR Early Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04433065
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : May 3, 2021
Information provided by (Responsible Party):
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.

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.

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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 : October 31, 2021
Estimated Study Completion Date : November 15, 2026

Arm Intervention/treatment
Experimental: Primary Cohort
Device: Intrepid TTVR System
Device: Intrepid™ TTVR System
Device: Intrepid™ TTVR System

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Preexisting mechanical or bioprosthetic heart valve in the tricuspid position
  • Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
  • Prohibitive tricuspid annular calcification
  • Aortic valve disease (moderate or severe aortic stenosis or severe aortic regurgitation) requiring intervention or previous intervention within 90 days of enrollment
  • Moderate or severe mitral regurgitation or previous intervention within 90 days of enrollment
  • 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
  • Subject is contraindicated for transesophageal echocardiography (TEE)
  • Systolic pulmonary artery pressure > 2/3 systemic systolic blood pressure and / or pulmonary vascular resistance ≥ 6 Woods Units not responsive to vasodilator infusion
  • Need for emergent or urgent surgery
  • Hemodynamic instability requiring either inotropic agents or mechanical circulatory support
  • Subject refuses a blood transfusion
  • Ongoing sepsis, including active endocarditis
  • Subject unwilling or unable to adhere to the protocol specified anticoagulation treatment
  • Blood dyscrasias as defined: leukopenia (WBC <1000 cells/mm3), thrombocytopenia (platelet count <50,000 cells/mm3)
  • History of bleeding diathesis or coagulopathy that precludes anticoagulation
  • Active gastrointestinal (GI) bleeding or history of GI bleed within the last 60 days prior to enrollment that would preclude anticoagulation
  • Known hypersensitivity or contraindication to nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
  • Any cardiac or peripheral interventional procedure performed within 90 days prior to enrollment
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Severe symptomatic carotid stenosis
  • Stroke or TIA within 90 days of enrollment
  • Acute myocardial infarction within 90 days of enrollment
  • Active infection requiring antibiotic therapy
  • Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within 90 days of enrollment
  • Subjects with pacemaker or ICD leads that would prevent appropriate valve placement
  • End stage renal disease requiring chronic dialysis or creatinine clearance < 30 cc/min within 30 days of the Index Procedure
  • Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by:

    • Forced Expiratory Volume (FEV1) < 750cc
    • Continuous home oxygen therapy
    • Chronic outpatient oral steroid use
  • Pulmonary embolism within the last 6 months
  • Chronic thromboembolic disease
  • Previously received a heart transplant
  • Severe uncontrolled arterial hypertension (SBP ≥ 180 mm Hg and / or DBP ≥ 110 mm Hg
  • Carcinoid tricuspid regurgitation
  • Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
  • Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint
  • Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams

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 identifier (NCT number): NCT04433065

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Contact: Sarah Brown 763-514-4000
Contact: Lynnett Stahl

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United States, Arizona
Abrazo Arizona Heart Hospital Recruiting
Phoenix, Arizona, United States, 85016
Principal Investigator: Timothy Byrne, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jessica Oakley         
Principal Investigator: Stanley Chetcuti, MD         
United States, New York
Columbia University Medical Center/NYPH Recruiting
New York, New York, United States, 10032
Principal Investigator: Susheel Kodali, 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         
Aurora Saint Luke's Medical Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Tanvir Bajwa, MD         
Sponsors and Collaborators
Medtronic Cardiovascular
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Responsible Party: Medtronic Cardiovascular Identifier: NCT04433065    
Other Study ID Numbers: MDT20009TMV003
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
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