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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 : August 16, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

Condition or disease Intervention/treatment Phase
Symptomatic Severe Aortic Stenosis Device: Navitor Transcatheter Aortic Valve and FlexNav Delivery System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
Actual Study Start Date : June 13, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : December 31, 2033

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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





Primary Outcome Measures :
  1. Primary safety and effectiveness endpoint is a composite of all-cause mortality or disabling stroke [ Time Frame: 12 months ]

Other Outcome Measures:
  1. 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 ]
  2. Non-hierarchical composite of all-cause mortality or stroke [ Time Frame: 12 months ]
  3. 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 ]
  4. Mortality (all-cause and cardiovascular-related) [ Time Frame: 30 days and 12 months ]
  5. Stroke (All stroke, disabling, and non-disabling) [ Time Frame: 30 days and 12 months ]
  6. Transient ischemic attack (TIA) [ Time Frame: 30 days and 12 months ]
  7. Bleeding (life threatening, disabling, and major) [ Time Frame: 30 days ]
  8. Major vascular complications at 30 days [ Time Frame: 30 days ]
  9. Acute kidney injury (Stage 3 requiring dialysis, Stage 3, and Stage 2) [ Time Frame: 30 days ]
  10. Permanent pacemaker insertion [ Time Frame: 30 days and 12 months ]
  11. Myocardial infarction [ Time Frame: 30 days and 12 months ]
  12. Coronary obstruction requiring intervention [ Time Frame: 30 days and 12 months ]
  13. 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 ]
  14. Rehospitalization (valve-related, procedure-related, or heart failure) [ Time Frame: 30 days and 12 months ]
  15. Paravalvular leak (none/trace, mild, moderate or severe) [ Time Frame: Discharge, 30 days, 12 months and annually (when collected) through 10 years ]
  16. 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 ]
  17. Aortic valve reintervention [ Time Frame: at 30 days, 12 months, and annually through 10 years ]
  18. Prosthetic valve endocarditis [ Time Frame: 12 months and annually through 10 years ]
  19. Structural valve deterioration [ Time Frame: 12 months and annually through 10 years ]
  20. Successful coronary access as needed [ Time Frame: 12 months and annually through 10 years ]
  21. Symptomatic prosthetic valve thrombosis [ Time Frame: 12 months and annually through 10 years ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04788888


Contacts
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Contact: Nadia Bouhdi +32479941037 nadia.bouhdi@abbott.com
Contact: Kyle Brunner 651-756-3482 kyle.brunner@abbott.com

Locations
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Australia
St. Andrew's Hospital Recruiting
Adelaide, Australia
Principal Investigator: Stephen Worthley         
The Alfred Hospital Recruiting
Melbourne, Australia
Principal Investigator: Tony Walton         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Principal Investigator: Lars Sondergaard         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Azeem Latib, MD Montefiore Health System
Principal Investigator: Michael Reardon, MD The Methodist Hospital Research Institute
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04788888    
Other Study ID Numbers: ABT-CIP-10342
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: August 16, 2021
Last Verified: August 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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction