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NCT04843072 · ClinicalTrials.gov registry record · NA
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
A NA study of Valve Heart Disease, sponsored by Erasmus Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 14
- Study locations
NCT04843072: Recruiting NA study of Valve Heart Disease, sponsored by Erasmus Medical Center.
NCT04843072 is a NA study of Valve Heart Disease that is actively recruiting participants, run by Erasmus Medical Center. The registered enrollment target is 400 participants, above the 72-participant average among 3 other Valve Heart Disease trials with a reported enrollment target (456% higher). The trial reports 14 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04843072, a NA study of Valve Heart Disease, is actively recruiting participants, sponsored by Erasmus Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 14
- Study locations
Study Summary
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses. Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success. Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro. Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus. Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by * Absence of procedural mortality AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location AND * Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean
Conditions Studied
Interventions
- DEVICE Evolut R/PRO bioprosthesis
- DEVICE Edwards Sapien S3/Ultra bioprosthesis
Study Locations (14)
Other
- Vienna General Hospital - Vienna
- St Paul's and Vancouver General Hospital - Vancouver
- Rigshospitalet - Copenhagen
- Institut Cœur Poumon - Lille
- Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany - Düsseldorf
- University Hospital Mainz - Mainz
- Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece - Athens
- Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy - Brescia
- University Hospital of Padova - Padua
- Erasmus Medical Centre - Rotterdam
- Centro Hospitalar de Lisboa Ocidental - Lisbon
- Inselspital, University Hospital - Bern
- Leeds Teaching Hospitals - Leeds
California
- Cedars Sinai - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2021-05-01 |
| Est. Completion | 2026-05-01 |
| Phase | NA |
What NCT04843072 shows while recruiting
NCT04843072 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 72-participant average among 3 other Valve Heart Disease trials with a reported enrollment target (456% higher).
The record links to 1 condition, with Valve Heart Disease appearing as the primary indexed condition, and to 2 interventions - of which Evolut R/PRO bioprosthesis is the first listed.
NCT04843072 lists 14 locations in 2 states (Other, California).
Frequently Asked Questions
What is clinical trial NCT04843072 about?
NCT04843072 is a clinical study titled "Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis". Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at th...
What is the current status of trial NCT04843072?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2021-05-01. Estimated completion is 2026-05-01.
What conditions does trial NCT04843072 study?
This clinical trial studies the following conditions: Valve Heart Disease.
What interventions are being tested in trial NCT04843072?
The interventions under investigation include: Evolut R/PRO bioprosthesis (DEVICE), Edwards Sapien S3/Ultra bioprosthesis (DEVICE).
Who is sponsoring clinical trial NCT04843072?
This trial is sponsored by Erasmus Medical Center, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04843072 being conducted?
This trial has 14 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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