NCT04843072 Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
| NCT ID | NCT04843072 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Valve Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2021-05-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 are performed using a bioprosthesis. Durability of surgical bioprostheses varies according to patient age at the time of implantation, prosthesis type and size, among other factors. TAVI has become an established treatment option for patients with a degenerated surgical aortic bioprosthesis. The time from index surgical aortic valve replacement (SAVR) to bioprosthetic valve degeneration is typically 8-10 years. TAVI in this setting has shown favorable outcomes. Balloon-expandable and self-expanding transcatheter heart valves (THVs) can both be used for the treatment of a degenerated surgical aortic bioprosthesis and have specific advantages and limitations. Valve-in-valve TAVI may be associated with coronary obstruction, THV migration, paravalvular regurgitation, and prosthesis-patient mismatch. Objective: To compare valve-in-valve TAVI with balloon-expandable SAPIEN/MYVAL THV series versus the self-expanding EVOLUT THV series. The primary analysis evaluates device success at 30 days in the primary cohort. Continued enrollment will additionally support a secondary comparison of the safety and efficacy of the SAPIEN and MYVAL THV series. Study design: International multicenter randomized study with 1:1 randomization to TAVI with the EVOLUT THV series or the SAPIEN/MYVAL THV series. Study population: The primary cohort comprises 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) selected for transfemoral TAVI by heart-team consensus. Enrollment of the primary cohort has been completed. The continued-enrollment cohort comprises 160 additional patients and will increase the total study population to 600 patients, with a target distribution of 300 patients treated with the EVOLUT THV series, 150 with the SAPIEN THV series, and 150 with the MYVAL THV series. Investigational intervention: Transfemoral valve-in-valve TAVI with a balloon-expandable SAPIEN or MYVAL THV series or a self-expanding EVOLUT THV series. Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by: * Absence of procedural mortality; AND * Technical success at exit from the procedure room defined as freedom from mortality, successful access, delivery of the device and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; AND * Intended performance of the prosthetic heart valve (no severe prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, Doppler velocity index ≥0.25, and no moderate or severe prosthetic valve regurgitation). Severe prosthesis-patient mismatch is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²/m² (≤0.55 cm²/m² if BMI ≥30 kg/m²). 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure, or valve-related problems. 3. Secondary objective is comparison of the safety and efficacy of the SAPIEN versus MYVAL THV series, including the incidence of moderate or severe prosthesis-patient mismatch. The continued-enrollment cohort is designed to support this comparison.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT). * Written informed consent Exclusion Criteria: * Not eligible for Transfemoral TAVI with EVOLUT, SAPIEN or MYVAL THV series * Multi-valve defects requiring intervention * Clinically unstable and/or inotropic/vasopressor /mechanical support. * Known mural thrombus in the left ventricle * Presence of a mechanical aortic valve * History of recent (within 1 month) stroke or TIA
Contact & Investigator
Nicolas Van Mieghem, MD, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Centre
Frequently Asked Questions
Who can join the NCT04843072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Valve Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04843072 currently recruiting?
Yes, NCT04843072 is actively recruiting participants. Contact the research team at r.nuis@erasmusmc.nl for enrollment information.
Where is the NCT04843072 trial being conducted?
This trial is being conducted at Los Angeles, United States, Vienna, Austria, Vancouver, Canada, Copenhagen, Denmark and 10 additional locations.
Who is sponsoring the NCT04843072 clinical trial?
NCT04843072 is sponsored by Erasmus Medical Center. The principal investigator is Nicolas Van Mieghem, MD, PhD at Erasmus Medical Centre. The trial plans to enroll 600 participants.