Unknown NA INTERVENTIONAL 2-arm NCT04160130

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

A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Transcatheter Aortic Valve Implantation in Female Patients Who Have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement

Sponsor: Edwards Lifesciences

Conditions Aortic Valve Stenosis Heart Valve Diseases

Interventions Transcatheter aortic valve replacement

Updated 15 times since 2019 Last updated: May 31, 2023 Started: Nov 29, 2019 Primary completion: Feb 29, 2024 Completion: Jun 30, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Aortic Valve Stenosis and Heart Valve Diseases and is currently ongoing. Edwards Lifesciences leads this study, which shows 15 recorded versions since 2019 — indicating substantial longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

Change History

15 versions recorded

Sep 2025 — Present [monthly]

Unknown NA
Jun 2025 — Sep 2025 [monthly]

Unknown NA

Status: Active Not Recruiting → Unknown
Sep 2024 — Jun 2025 [monthly]

Active Not Recruiting NA
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting NA
Jul 2023 — Jul 2024 [monthly]

Active Not Recruiting NA

Status: Recruiting → Active Not Recruiting

▶ Show 10 earlier versions

Mar 2023 — Jul 2023 [monthly]

Recruiting NA
Feb 2023 — Mar 2023 [monthly]

Recruiting NA
Mar 2022 — Feb 2023 [monthly]

Recruiting NA
Sep 2021 — Mar 2022 [monthly]

Recruiting NA
Jan 2021 — Sep 2021 [monthly]

Recruiting NA
Dec 2020 — Jan 2021 [monthly]

Recruiting NA
Oct 2020 — Dec 2020 [monthly]

Recruiting NA
Jul 2020 — Oct 2020 [monthly]

Recruiting NA
May 2020 — Jul 2020 [monthly]

Recruiting NA

Status: Not Yet Recruiting → Recruiting
Dec 2019 — May 2020 [monthly]

Not Yet Recruiting NA

First recorded

Nov 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Edwards Lifesciences
Optimapharm

Data source: Optimapharm

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bad Oeynhausen, Germany , Berlin, Germany , Bern, Switzerland , Bordeaux, France , Bouge, Belgium , Brest, France , Bron, France , Catania, Italy , Charleroi, Belgium , Clermont-Ferrand, France and 36 more locations