Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation

N/ATerminatedNCT01982032

UMC Utrecht56 enrolled

Overview

Transcatheter aortic valve replacement (TAVR) is a good alternative treatment for patients with severe aortic valve stenosis with similar mid-term success rates as compared to surgery. Periprosthetic aortic regurgitation (PAR) after TAVR remains an important limitation of this technique. Moderate to severe PAR occurs in 15-45% of the cases and it is an independent predictor of mortality after TAVR. Little is known about potential differences in severity of PAR among different types of aortic valve prosthesis. The current randomized study aims to evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic CoreValve® system with main focus on PAR and additional focus on other clinical and imaging endpoints. Primary objective of this study is to investigate the difference in the severity of PAR, measured with 3-dimensional transesophageal echocardiography (3DTEE), between patients undergoing the implantation of the Edwards SAPIEN bioprosthesis versus patients receiving the Medtronic CoreValve® bioprosthesis. Secondary objectives of this study include: investigating the value of different imaging modalities in evaluating periprosthetic regurgitation after TAVR and studying the difference in clinical endpoints according to VARC-2 definitions and quality of life after TAVR between two available aortic valve prostheses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periprosthetic Aortic Valve Regurgitation After TAVI

Interventions

Transcatheter aortic valve replacementPROCEDURE

Transcatheter aortic valve replacement

Medtronic CoreValve systemDEVICE

Transcatheter aortic valve replacement with the Medtronic CoreValve system

Edwards SAPIEN bioprosthesisDEVICE

Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria In order to be eligible to participate in this study, subjects must meet all of the following criteria: * Patient is ≥18 years of age and diagnosed with severe symptomatic aortic stenosis, judged inoperable or at high surgical risk (EuroSCORE \> 15% or other criteria that make surgery high risk by a consensus among cardiologists and cardiac surgeons in the heart team) and deemed eligible for transfemoral-TAVI. * Aortic annulus diameter ≥ 18 and ≤ 29 mm as assessed with MSCT. * No contraindications to study requirements such as MRI or TEE. Exclusion criteria * Patients unable or unwilling to give informed consent. * Patients who are excluded from this study because of the size of their aortic annulus diameter.

Outcomes

Primary Outcomes

PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE

PAR (expressed as regurgitant volume \[ml\]) after TAVR, as diagnosed with 3DTEE

Time frame: Within 5 days after TAVR

Secondary Outcomes

PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging

PAR (expressed as regurgitant volume \[ml\]) after TAVR, as diagnosed with cardiac magnetic resonance imaging

Time frame: Within 5 days after TAVR

PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE

PAR (expressed as regurgitant volume \[ml\]) 6 months after TAVR, as diagnosed with 3DTEE

Time frame: At 6 months +/- 2 weeks after TAVR

Clinical endpoints according to the VARC-2

Time frame: 30 days, 6months, 1 year

Quality of life, presented as scores of the short form 36 item health status survey (SF-36)

Time frame: 1 year

Quality of life, according to the Euroqol questionnaire (EQ-5D)

Quality of life, presented as scores of the Euroqol questionnaire (EQ-5D)