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Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II

NCT03192813 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 796

Last updated 2020-06-11

No results posted yet for this study

Summary

Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Symetis ACURATE neo™ transfemoral TAVI system

Symetis ACURATE neo™ transfemoral TAVI system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to mitigate paravalvular regurgitation (manufactured by Symetis SA, Ecublens, Switzerland).

DEVICE

Medtronic CoreValve Evolut R TAVI System

Medtronic CoreValve Evolut R Transcatheter Aortic Valve Implantation (TAVI) System (or any future CE-marked Corevalve versions): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).

Sponsors & Collaborators

  • Symetis SA

    collaborator INDUSTRY

  • Ceric Sàrl

    lead INDUSTRY

Principal Investigators

  • Corrado Tamburino, Prof, MD, PhD · Cardiology Division and Cardio-Thoracic & Vascular Department, Ferrarotto & Policlinico Hospitals, University of Catania, Italy

  • Sabine Bleiziffer, MD · Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2020-06-04
Completion
2020-06-04

Countries

  • Denmark
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03192813 on ClinicalTrials.gov