Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

NCT04843072 | Recruiting FDA Device

• 1 other identifier: BASELINE TRIAL
• Study Type: interventional
• Target: 400
• Locations: 12 countries
• Sites: 14

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 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:

• 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 aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2
• Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.

Conditions

Valve Heart Disease

Outcome Measures

Primary Outcomes (1)

• Device success

  Device success, definition modified from VARC-2 criteria: * 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 aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2

  30 days post transcatheter valve implantation

Secondary Outcomes (1)

• Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems

  1 year post transcatheter valve implantation

Study Arms (2)

Evolut R/Pro bioprosthesis

EXPERIMENTAL

Study subjects will receive a self-expanding-valve (either the Evolut R or PRO device)

Device: Evolut R/PRO bioprosthesis

Edwards Sapien S3/Ultra bioprosthesis

ACTIVE COMPARATOR

Study subjects will receive a balloon-expanding-valve (either the Edwards Sapien S3 or Ultra)

Device: Edwards Sapien S3/Ultra bioprosthesis

Interventions

Evolut R/PRO bioprosthesis DEVICE

To compare Evolut R/PRO versus Sapien S3/Ultra in failing surgical bioprostheses

Evolut R/Pro bioprosthesis

Edwards Sapien S3/Ultra bioprosthesis DEVICE

Edwards Sapien S3/Ultra bioprosthesis

Edwards Sapien S3/Ultra bioprosthesis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 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

You may not qualify if:

• Not eligible for Transfemoral TAVI with SAPIEN-3 / Ultra and Evolut R/Pro
• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (14)

Cedars Sinai

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Vienna General Hospital

Vienna, Austria

NOT YET RECRUITING

St Paul's and Vancouver General Hospital

Vancouver, Canada

NOT YET RECRUITING

Rigshospitalet

Copenhagen, Denmark

NOT YET RECRUITING

Institut Cœur Poumon

Lille, France

NOT YET RECRUITING

Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany

Düsseldorf, Germany

RECRUITING

University Hospital Mainz

Mainz, Germany

NOT YET RECRUITING

Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece

Athens, Greece

RECRUITING

Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy

Brescia, Italy

RECRUITING

University Hospital of Padova

Padua, Italy

NOT YET RECRUITING

Erasmus Medical Centre

Rotterdam, 3015 GD, Netherlands

RECRUITING

Centro Hospitalar de Lisboa Ocidental

Lisbon, Portugal

NOT YET RECRUITING

Inselspital, University Hospital

Bern, Switzerland

NOT YET RECRUITING

Leeds Teaching Hospitals

Leeds, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• Nuis RJ, van Belle E, Teles R, Blackman D, Veulemans V, Santos IA, Pilgrim T, Tarantini G, Saia F, Iakovou I, Mascherbauer J, Vincent F, Geleijnse M, Sathananthan J, Wood D, Makkar R, Van Mieghem NM; BASELINE Investigators. BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial. Am Heart J. 2023 Feb;256:139-147. doi: 10.1016/j.ahj.2022.11.013. Epub 2022 Nov 19.

  PMID: 36410441 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nicolas Van Mieghem, MD, PhD

  Erasmus Medical Centre

  PRINCIPAL INVESTIGATOR

• Rutger-Jan Nuis, MD, PhD

  Erasmus Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rutger-Jan Nuis, MD, PhD

CONTACT

+31614858291; r.nuis@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 13, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); GB (1); AU (1); PT (1); DK (1); CH (1); FR (1); GR (1); DE (2); CA (1); IT (2); US (1)