Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

Part of paid clinical trials in Los Angeles, California.

Sponsor
Erasmus Medical Center
Study ID
NCT04843072
Status
Recruiting
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Conditions

  • Valve Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EVOLUT R/PRO/PRO+/FX bioprosthesis — DEVICE
    To compare EVOLUT R/PRO/PRO+/FX bioprosthesis versus Edwards SAPIEN 3/Ultra bioprosthesis or Myval/Octacor/ Octapro in failing surgical bioprostheses
  • Edwards Sapien S3/Ultra bioprosthesis — DEVICE
    Edwards Sapien S3/Ultra bioprosthesis
  • MYVAL/Octacor/Octapro bioprosthesis — DEVICE
    MYVAL/Octacor/Octapro bioprosthesis

Study Details

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.

Key Dates

First listed
Apr 13, 2021
Start date
May 1, 2021
Status verified
Oct 2026
Primary completion
Jun 1, 2028
Completion
May 1, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EVOLUT R/PRO/PRO+/FX bioprosthesis
    Study subjects will receive a self-expanding valve from the EVOLUT THV series (EVOLUT R/PRO/PRO+/FX).
  • Active Comparator: SAPIEN 3/Ultra or MYVAL/Octacor/Octapro bioprosthesis
    Study subjects will receive a balloon-expandable valve from either the SAPIEN THV series (SAPIEN 3, SAPIEN 3 Ultra) or the MYVAL THV series (Myval Octacor, Myval Octapro).

Primary Outcome Measure

Device success [ Time Frame: 30 days post transcatheter valve implantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars SinaiLos AngelesCalifornia90048
Raj Makkar, MD
Raj Makkar, MD (PRINCIPAL_INVESTIGATOR)

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Cedars Sinai· Los Angeles, CA

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