Clinical Trials Logo
  1. Home
  2. Valve Heart Disease
  3. NCT04843072

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis — BASELINE  

Valve Heart Disease Clinical Trial

Official title:
Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.

Clinical Trial 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 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 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04843072
Study type Interventional
Source Erasmus Medical Center
Contact Rutger-Jan Nuis, MD, PhD
Phone +31614858291
Email r.nuis@erasmusmc.nl
Status Recruiting
Phase N/A
Start date May 1, 2021
Completion date May 1, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT05079672 - Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery Phase 4
Completed NCT03347851 - Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Completed NCT04328090 - Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship N/A
Recruiting NCT04359030 - Freestyle-Perimount Calcification Comparison
Completed NCT04958668 - Prospective Evaluation of Volatile Sedation After Heart Valve Surgery N/A
Completed NCT04598360 - Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine) N/A
Not yet recruiting NCT04118621 - Role of Chest Ultrasound in Detection of Post-operative Pulmonary Complications After Cardiothoracic Surgery
Completed NCT05804500 - RecoveryPlus Telerehab Platform Pilot Study N/A
Recruiting NCT03885180 - Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy N/A
Recruiting NCT06154018 - Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass. N/A
Recruiting NCT06041308 - Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve
Suspended NCT01571791 - Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery Phase 2
Completed NCT06261788 - Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter N/A
Completed NCT06079008 - The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients
Completed NCT04372654 - Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients N/A
Active, not recruiting NCT03661398 - Caisson Transcatheter Mitral Valve Replacement (TMVR) N/A
Recruiting NCT03595423 - SPAnish Aortic VALVE Multicentric Study
Terminated NCT03566303 - Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis Phase 2/Phase 3