Portico and Navitor India Clinical Trial

Last updated: February 28, 2025
Sponsor: Abbott Medical Devices
Overall Status: Completed

Phase

N/A

Condition

Congestive Heart Failure

Heart Defect

Treatment

Transcatheter Aortic Valve Replacement

Clinical Study ID

NCT05171712
ABT-CIP-10387
  • Ages > 60
  • All Genders

Study Summary

The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must provide written informed consent prior to any clinicalinvestigation-related procedure.

  2. Are >60 years of age in host country, have severe symptomatic (NYHA class ≥ II)aortic stenosis (AS), at high or extreme surgical risk and have been identified as acandidate for a Portico or Navitor valve implant.

  3. Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documentedheart team agreement of high or extreme risk for surgical aortic valve replacementdue to frailty or co-morbidities not captured by the STS score.

Exclusion

Exclusion Criteria:

  1. Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any timeAND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lungtissue, etc.)

  2. Have sepsis, including active endocarditis

  3. Have any evidence of left ventricular or atrial thrombus

  4. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severecalcification) that make insertion and endovascular access to the aortic valveimprobable

  5. Have a non-calcified aortic annulus

  6. Have congenital bicuspid or unicuspid leaflet configuration

  7. Are unable to tolerate antiplatelet/anticoagulant therapy

  8. Are pregnant at the time of signing informed consent

  9. Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Transcatheter Aortic Valve Replacement
Phase:
Study Start date:
May 06, 2022
Estimated Completion Date:
January 28, 2025

Study Description

The objective of this Phase IV clinical trial is to characterize the procedural safety and device performance of the Portico valve, the Navitor Valve, the FlexNav delivery system and FlexNav or Navitor loading system to treat patients with severe aortic stenosis.

Connect with a study center

  • Apollo Hospital

    Chennai,
    India

    Site Not Available

  • Medanta-The Medicity

    Gurgaon,
    India

    Site Not Available

  • Rajasthan Hospital

    Jaipur,
    India

    Site Not Available

  • Seth GS Medical College & KEM Hospital

    Mumbai,
    India

    Site Not Available

  • Vardhman Mahavir Medical College & Safdarjung Hospital

    New Delhi,
    India

    Site Not Available

  • Christian Medical College & Hospital

    Vellore,
    India

    Site Not Available

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