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Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
NCT04843072 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04843072
The ClinicalTrials.gov registry entry for NCT04843072 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Erasmus Medical Center, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04843072 reports 14 study locations spanning 2 distinct geographic areas — top geographies include Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04843072?
The interventions under investigation include: Evolut R/PRO bioprosthesis (DEVICE), Edwards Sapien S3/Ultra bioprosthesis (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04843072?
This trial is sponsored by Erasmus Medical Center, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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