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Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation (VANTAGE)

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ClinicalTrials.gov Identifier: NCT04788888
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE March 2, 2021
First Posted Date  ICMJE March 9, 2021
Last Update Posted Date January 9, 2023
Actual Study Start Date  ICMJE June 13, 2021
Estimated Primary Completion Date April 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2021)		 Primary safety and effectiveness endpoint is a composite of all-cause mortality or disabling stroke [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2021)
  • Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications [ Time Frame: 30 days ]
  • Non-hierarchical composite of all-cause mortality or stroke [ Time Frame: 12 months ]
  • Procedural success defined as successful vascular access, delivery and deployment of the Navitor valve; retrieval with the delivery system and correct positioning of a single Navitor valve in the proper anatomical location and no procedural mortality [ Time Frame: Procedure ]
  • Mortality (all-cause and cardiovascular-related) [ Time Frame: 30 days and 12 months ]
  • Stroke (All stroke, disabling, and non-disabling) [ Time Frame: 30 days and 12 months ]
  • Transient ischemic attack (TIA) [ Time Frame: 30 days and 12 months ]
  • Bleeding (life threatening, disabling, and major) [ Time Frame: 30 days ]
  • Major vascular complications at 30 days [ Time Frame: 30 days ]
  • Acute kidney injury (Stage 3 requiring dialysis, Stage 3, and Stage 2) [ Time Frame: 30 days ]
  • Permanent pacemaker insertion [ Time Frame: 30 days and 12 months ]
  • Myocardial infarction [ Time Frame: 30 days and 12 months ]
  • Coronary obstruction requiring intervention [ Time Frame: 30 days and 12 months ]
  • Changes in functional status from baseline to follow-up assessments (e.g., NYHA classification, six-minute walk test, quality of life measures) [ Time Frame: 30 days and 12 months ]
  • Rehospitalization (valve-related, procedure-related, or heart failure) [ Time Frame: 30 days and 12 months ]
  • Paravalvular leak (none/trace, mild, moderate or severe) [ Time Frame: Discharge, 30 days, 12 months and annually (when collected) through 10 years ]
  • Changes in echocardiographic parameters from baseline to follow-up (e.g., mean effective orifice area, mean transvalvular gradient) [ Time Frame: 30 days, 12 months and annually (when collected) through 10 years ]
  • Aortic valve reintervention [ Time Frame: at 30 days, 12 months, and annually through 10 years ]
  • Prosthetic valve endocarditis [ Time Frame: 12 months and annually through 10 years ]
  • Structural valve deterioration [ Time Frame: 12 months and annually through 10 years ]
  • Successful coronary access as needed [ Time Frame: 12 months and annually through 10 years ]
  • Symptomatic prosthetic valve thrombosis [ Time Frame: 12 months and annually through 10 years ]
Original Other Pre-specified Outcome Measures
 (submitted: March 8, 2021)
  • Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications [ Time Frame: 30 days ]
  • Non-hierarchical composite of all-cause mortality or stroke [ Time Frame: 12 months ]
 
Descriptive Information
Brief Title  ICMJE Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
Official Title  ICMJE VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
Brief Summary Evaluation of TAVR using the NAVITOR valve in a Global Investigation.
Detailed Description The VANTAGE clinical trial will evaluate the safety and effectiveness of the Navitor valve in patients with severe, symptomatic aortic stenosis who are at intermediate or low risk of surgical mortality. This trial will also evaluate the safety and effectiveness of the Navitor valve in a valve-in-valve application.
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 Symptomatic Severe Aortic Stenosis
Intervention  ICMJE Device: Navitor Transcatheter Aortic Valve and FlexNav Delivery System

For traditional application, the Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.

For the valve-in-valve application, the Navitor valve is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve.

Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system
Study Arms  ICMJE Experimental: Navitor Transcatheter Aortic Valve, FlexNav Delivery System
Navitor valve implantation, FlexNav Delivery system (small and large) and and Navitor Loading System (small and large)
Intervention: Device: Navitor Transcatheter Aortic Valve and FlexNav Delivery 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: May 11, 2022)		 590
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2021)		 550
Estimated Study Completion Date  ICMJE February 28, 2036
Estimated Primary Completion Date April 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In the judgement of the site's heart team, subject is deemed to be at intermediate or low risk for open surgical aortic valve replacement (i.e., heart team estimates risk of surgical mortality < 7% at 30 days, considering the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator
  • New York Heart Association (NYHA) Functional Classification of II, III, or IV

Exclusion Criteria:

  • Evidence of an acute myocardial infarction [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)] within 30 days prior to index procedure
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or ICD implant) to index procedure or planned within 30 days following the index procedure.
  • Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³); history of bleeding diathesis or coagulopathy
  • Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
  • Renal insufficiency (creatinine > 3.0 mg/dL or estimated GFR <30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis
  • Untreated atrial fibrillation (e.g., patients with atrial fibrillation not on anticoagulants)
  • Symptomatic carotid or vertebral artery disease, significant carotid or vertebral artery disease requiring intervention, or successful treatment of carotid or vertebral stenosis within 30 days prior to index procedure
  • Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
  • Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nadia Bouhdi +32 479 94 10 37 nadia.bouhdi@abbott.com
Contact: Hai-Chien Kuo +1 408-221-6366 hai-chien.kuo@abbott.com
Listed Location Countries  ICMJE Australia,   Denmark,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04788888
Other Study ID Numbers  ICMJE ABT-CIP-10342
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abbott Medical Devices
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Azeem Latib, MD Montefiore Health System
Principal Investigator: Michael Reardon, MD The Methodist Hospital Research Institute
PRS Account Abbott Medical Devices
Verification Date January 2023

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