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VISTA: Post-Market Clinical Follow Up Study With Navitor Valve

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06008080
Collaborator
(none)
1,000
Enrollment
86
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

Condition or Disease Intervention/Treatment Phase
  • Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

Detailed Description

The VISTA Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
VISTA Study (Navitor Post-Market Clinical Follow Up Study)
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

The Navitor valve is available in four valve sizes to cover annulus diameters from 19 mm to 27 mm. The FlexNav delivery system is available in two sizes, small and large. The Navitor loading system is an accessory used to compress and load the Navitor valve onto the FlexNav delivery system and is available in two sizes, small and large.

Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System

Outcome Measures

Primary Outcome Measures

  1. All-cause mortality at 30 days post-TAVI procedure [30 days post index procedure]

    Death from all causes at 30 days post-TAVI procedure

  2. Moderate or greater paravalvular leak at 30 days post-TAVI procedure [30 days post index procedure]

    Assessment of paravalvular leak at 30 days post-TAVI procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • The patient is scheduled to undergo a Navitor TAVI procedure.

  • The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the IRB (Investigational Review Board)/EC (Ethics Committee) of the respective clinical site.

  • The patient and the treating physician agree that the subject will return for all required post procedure follow up visits.

Exclusion Criteria:

  • Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.

  • In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.

  • Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.

  • Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.

  • Currently participating in an investigational drug or device study that may confound the results of this study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Principal Investigator: Alper Öner, MD, Universitätsmedizin Rostock, Germany
  • Principal Investigator: Nicolas Dumonteil, MD, Clinique Pasteur Toulouse, France
  • Study Director: Vinny Podichetty, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT06008080
Other Study ID Numbers:
  • ABT-CIP-10476
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Abbott Medical Devices
NAVITOR
Transcatheter aortic valve implantation (TAVI)
Aortic Stenosis
Cardiovascular Disease
Additional relevant MeSH terms:
Aortic Valve Stenosis

Study Results

No Results Posted as of Aug 28, 2023