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Trial record 2 of 2 for:    Medtronic intrepid

TTVR Early Feasibility Study

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ClinicalTrials.gov Identifier: NCT04433065
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Tracking Information
First Submitted Date  ICMJE June 4, 2020
First Posted Date  ICMJE June 16, 2020
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE October 20, 2020
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • 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)
  • Change in TR Grade from baseline [ Time Frame: Through 30 days post-procedure ]
    Change in TR Grade from baseline
  • Rate of no significant TV stenosis [ Time Frame: Through 30 days post-procedure ]
    Rate of no significant TV stenosis
  • Change in NYHA Class from baseline [ Time Frame: Through 30 days post-procedure ]
    Change in NYHA Class from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TTVR Early Feasibility Study
Official Title  ICMJE The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tricuspid Regurgitation
Intervention  ICMJE Device: Intrepid™ TTVR System
Device: Intrepid™ TTVR System
Study Arms  ICMJE Experimental: Primary Cohort
Device: Intrepid TTVR System
Intervention: Device: Intrepid™ TTVR System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2020)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2026
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Brown 763-514-4000 rs.tmvrtransfemoralefs@medtronic.com
Contact: Lynnett Stahl rs.tmvrtransfemoralefs@medtronic.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04433065
Other Study ID Numbers  ICMJE MDT20009TMV003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Cardiovascular
Study Sponsor  ICMJE Medtronic Cardiovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Cardiovascular
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP