Edwards SAPIEN periprosthetic leakage evaluation versus Medtronic CoreValve in tranfemoral aortic valve implantation: the ELECT trial
Completed
- Conditions
- Aortic valve stenosisnarrowing of the native aortic valve10046973
- Registration Number
- NL-OMON41687
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
Inclusion Criteria
1)Patient is 18 years of age or older and diagnosed with severe symptomatic aortic stenosis, judged inoperable or at high surgical risk (EuroSCORE < 15%) and deemed eligible for TAVI by a consensus among a cardiologist and a cardiac surgeon (heart-team), 2) Or a patient who is considered to be operable by the heart-team, but who chooses to undergo TAVI instead of conventional surgery, 3) Annulus diameter *18 and *28, 4) Patients who undergo a transcatheter aortic valve implantation via the transfemoral approach
Exclusion Criteria
1) Patients with contraindications for transesophageal echocardiography (TEE)
2) Patients unable to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is post-TAVI periprosthetic aortic regurgitation measured<br /><br>with 3DTEE and new developed special software. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives of this study include: investigating the value of<br /><br>different imaging modalities in evaluating periprosthetic regurgitation after<br /><br>TAVI and studying the difference in clinical endpoints according to VARC-2<br /><br>definitions and quality of life after TAVI between two available aortic valve<br /><br>prostheses. </p><br>