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RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)

NCT04160130 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2023-06-01

No results posted yet for this study

Summary

Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery systems will be sued, for SAVR any commercially available surgical bioprosthetic valve. Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge, 30 day, 6 months (telephone contact) and 1 year.

Conditions

  • Aortic Valve Stenosis
  • Heart Valve Diseases

Interventions

PROCEDURE

Transcatheter aortic valve replacement

Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVI) or aortic valve replacement with a commercially available surgical bioprosthetic valve.

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Optimapharm

    lead INDUSTRY

Principal Investigators

  • Hélène Eltchaninoff, Prof. · CHU Rouen - Hopital Charles Nicolle

  • Didier Tchétché, Dr. · Clinique Pasteur Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2024-02-29
Completion
2024-06-30

Countries

  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Switzerland
  • 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 NCT04160130 on ClinicalTrials.gov