Edwards SAPIEN Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation (the ELECT Trial) (ELECT)

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2016 by UMC Utrecht

Sponsor:

Information provided by (Responsible Party):

Prof. Pieter Stella, UMC Utrecht

ClinicalTrials.gov Identifier:

NCT01982032

First received: August 27, 2013

Last updated: June 3, 2016

Last verified: June 2016

History of Changes

Purpose

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.

Condition	Intervention
Periprosthetic Aortic Valve Regurgitation After TAVI	Procedure: Transcatheter aortic valve replacement Device: Medtronic CoreValve system Device: Edwards SAPIEN bioprosthesis


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE [ Time Frame: Within 5 days after TAVR ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging [ Time Frame: Within 5 days after TAVR ] [ Designated as safety issue: No ]
PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE [ Time Frame: At 6 months +/- 2 weeks after TAVR ] [ Designated as safety issue: No ]
Clinical endpoints according to the VARC-2 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Quality of life, presented as scores of the short form 36 item health status survey (SF-36) and the Euroqol questionnaire (EQ-5D) [ Time Frame: 1 year ] [ Designated as safety issue: No ]


Estimated Enrollment:	108
Study Start Date:	November 2013
Estimated Study Completion Date:	November 2016
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Edwards SAPIEN bioprosthesis Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis	Procedure: Transcatheter aortic valve replacement Transcatheter aortic valve replacement Device: Edwards SAPIEN bioprosthesis Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
Active Comparator: Medtronic CoreValve® system Transcatheter aortic valve replacement with the Medtronic CoreValve system	Procedure: Transcatheter aortic valve replacement Transcatheter aortic valve replacement Device: Medtronic CoreValve system Transcatheter aortic valve replacement with the Medtronic CoreValve system

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982032

Contacts


Contact: Masieh Abawi	0031887559497	m.abawi@umcutrecht.nl

Locations


Netherlands
University Medical Center Utrecht	Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Masieh Abawi 0031887559497 m.abawi@umcutrecht.nl
Contact: Pierfrancesco Agostoni, MD, Phd 0031887556167 agostonipf@gmail.com

Sponsors and Collaborators

UMC Utrecht

Investigators


Principal Investigator:	Pieter Stella, MD, PhD	UMC Utrecht
Study Chair:	Pierfrancesco Agostoni, MD, PhD	UMC Utrecht
Study Director:	Masieh Abawi	UMC Utrecht

More Information


Responsible Party:	Prof. Pieter Stella, Interventional Cardiologist, UMC Utrecht
ClinicalTrials.gov Identifier:	NCT01982032 History of Changes
Other Study ID Numbers:	NL43116.041.13
Study First Received:	August 27, 2013
Last Updated:	June 3, 2016
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:


Periprosthetic aortic valve regurgitation 3D transesophageal echocardiography Cardiac MRI

Additional relevant MeSH terms:


Aortic Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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