+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Rationale and design of the Edwards SAPIEN-3 periprosthetic leakage evaluation versus Medtronic CoreValve in transfemoral aortic valve implantation (ELECT) trial : A randomised comparison of balloon-expandable versus self-expanding transcatheter aortic valve prostheses



Rationale and design of the Edwards SAPIEN-3 periprosthetic leakage evaluation versus Medtronic CoreValve in transfemoral aortic valve implantation (ELECT) trial : A randomised comparison of balloon-expandable versus self-expanding transcatheter aortic valve prostheses



Netherlands Heart Journal 25(5): 318-329



Periprosthetic aortic regurgitation (PPR) after transcatheter aortic valve implantation (TAVI) remains an important issue associated with impaired long-term outcomes. The current randomised study aims to evaluate potential differences between the balloon-expandable Edwards SAPIEN-3 and the self-expanding Medtronic CoreValve system with the main focus on post-TAVI PPR by means of novel imaging endpoints, and an additional focus on other clinical endpoints. The primary endpoint of this study is quantitative assessment of the severity of post-procedural PPR using cardiac magnetic resonance imaging. Several other novel imaging modalities (X-ray contrast angiography, echocardiography) are used as secondary imaging modalities for the assessment of PPR following TAVI. Secondary objectives of the study include clinical outcomes such as cerebral and kidney injury related to TAVI, and quality of life. The ELECT study is a single-centre, prospective, two-armed randomised controlled trial. For the purpose of this study, 108 consecutive adult patients suitable for transfemoral TAVI will be randomly allocated to receive the SAPIEN-3 (n = 54) or the CoreValve system (n = 54). The ELECT trial is the first randomised controlled trial to quantitatively compare the extent of post-TAVI PPR between the SAPIEN-3 and CoreValve. Furthermore, it will evaluate potential differences between the two prostheses with regard to mid-term clinical outcome and quality of life.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 058695735

Download citation: RISBibTeXText

PMID: 27943176

DOI: 10.1007/s12471-016-0934-3


Related references

The balloon-expandable Edwards Sapien 3 valve is superior to the self-expanding Medtronic CoreValve in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation. Journal of Cardiology 69(6): 877-882, 2017

TCT-630 Transfemoral aortic valve implantation (TAVI) with the balloon-expandable Edwards Sapien 3 valve compared with the self-expanding Medtronic CoreValve. Journal of the American College of Cardiology 66(15): B257-B258, 2015

Radiation dose of patients undergoing transcatheter aortic valve implantation: a comparison between Edwards SAPIEN XT and Medtronic CoreValve aortic valve prostheses. Catheterization and Cardiovascular Interventions 82(4): E578, 2013

Lower cardiovascular mortality with Medtronic CoreValve versus Edwards SAPIEN in patients with aortic valve stenosis undergoing transcatheter aortic valve implantation. International Journal of Cardiology 177(2): 520-522, 2014

Aortic Regurgitation in Patients Undergoing Transcatheter Aortic Valve Replacement With the Self-Expanding CoreValve Versus the Balloon-Expandable SAPIEN XT Valve. American Journal of Cardiology 117(9): 1502-1510, 2016

Immediate and mid-term results of transfemoral aortic valve implantation using either the Edwards Sapien transcatheter heart valve or the Medtronic CoreValve System in high-risk patients with aortic stenosis. Archives of Cardiovascular Diseases 103(4): 236-245, 2010

Clinical outcome and paravalvular leakage of the new balloon-expandable Edwards Sapien 3 valve in comparison to its predecessor model (Edwards Sapien XT) in patients undergoing transfemoral aortic valve replacement. Catheterization and Cardiovascular Interventions 88(3): 466-475, 2016

Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic valve implantation: Difference of valve selection in the real world. Journal of Cardiology 69(3): 565-569, 2017

Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN XT versus SAPIEN prostheses. Archives of Cardiovascular Diseases 105(3): 132-140, 2012

Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison. Circulation. Cardiovascular Interventions 8(6): E002408, 2015

The incidence of transcatheter aortic valve implantation-related heart block in self-expandable Medtronic CoreValve and balloon-expandable Edwards valves. Journal of Invasive Cardiology 24(4): 173-176, 2012

Comparison of the Edwards SAPIEN S3 Versus Medtronic Evolut-R Devices for Transcatheter Aortic Valve Implantation. American Journal of Cardiology 119(2): 302-307, 2017

Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve - rationale and design of a multicentre registry (EASE-IT TF). Bmc Cardiovascular Disorders 16(1): 223, 2016

Emergency transfemoral aortic valve-in-valve implantation with the balloon-expandable Edwards-Sapien valve. Journal of Cardiovascular Medicine 10(12): 936-939, 2009

Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve. International Journal of Cardiology 195: 171-175, 2015