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

Not Applicable

Terminated

• Conditions: Periprosthetic Aortic Valve Regurgitation After TAVI
• Interventions: Procedure: Transcatheter aortic valve replacement; Device: Medtronic CoreValve system; Device: Edwards SAPIEN bioprosthesis

• Registration Number: NCT01982032
• Lead Sponsor: UMC Utrecht

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-27
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Primary Completion: 2016-05
• Study Completion: 2017-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edwards SAPIEN bioprosthesis	Transcatheter aortic valve replacement	Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
Medtronic CoreValve® system	Transcatheter aortic valve replacement	Transcatheter aortic valve replacement with the Medtronic CoreValve system
Medtronic CoreValve® system	Medtronic CoreValve system	Transcatheter aortic valve replacement with the Medtronic CoreValve system
Edwards SAPIEN bioprosthesis	Edwards SAPIEN bioprosthesis	Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis

Primary Outcome Measures

Name	Time	Method
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE	Within 5 days after TAVR	PAR (expressed as regurgitant volume \[ml\]) after TAVR, as diagnosed with 3DTEE

Secondary Outcome Measures

Name	Time	Method
PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE	At 6 months +/- 2 weeks after TAVR	PAR (expressed as regurgitant volume \[ml\]) 6 months after TAVR, as diagnosed with 3DTEE
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging	Within 5 days after TAVR	PAR (expressed as regurgitant volume \[ml\]) after TAVR, as diagnosed with cardiac magnetic resonance imaging
Clinical endpoints according to the VARC-2	30 days, 6months, 1 year	Clinical endpoints according to the VARC-2
Quality of life, according to the Euroqol questionnaire (EQ-5D)	1 year	Quality of life, presented as scores of the Euroqol questionnaire (EQ-5D)
Quality of life, presented as scores of the short form 36 item health status survey (SF-36)	1 year	Quality of life, presented as scores of the short form 36 item health status survey (SF-36)

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands