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

NCT01982032 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-11-08

No results posted yet for this study

Summary

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.

Conditions

  • Periprosthetic Aortic Valve Regurgitation After TAVI

Interventions

PROCEDURE

Transcatheter aortic valve replacement

Transcatheter aortic valve replacement

DEVICE

Medtronic CoreValve system

Transcatheter aortic valve replacement with the Medtronic CoreValve system

DEVICE

Edwards SAPIEN bioprosthesis

Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Pieter Stella, MD, PhD · UMC Utrecht

  • Pierfrancesco Agostoni, MD, PhD · UMC Utrecht

  • Nynke Kooistra, MD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-05-31
Completion
2017-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01982032 on ClinicalTrials.gov