Edwards SAPIEN periprosthetic leakage evaluation versus Medtronic CoreValve in tranfemoral aortic valve implantation: the ELECT trial

Edwards SAPIEN periprosthetic leakage evaluation versus Medtronic CoreValve in tranfemoral aortic valve implantation: the ELECT trial - ELECT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41687

Enrollment

108

Registered

2013-08-15

Start date

2013-11-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic valve stenosis narrowing of the native aortic valve

Interventions

All TAVI will be performed via the femoral artery. One group of patients will receive the balloon expandable Edwards SAPIEN bioprosthesis and the other group will receive the self-expanding Medtroni

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1) Patients with contraindications for transesophageal echocardiography (TEE) 2) Patients unable to give informed consent

Design outcomes

Primary

Measure	Time frame
The primary endpoint is post-TAVI periprosthetic aortic regurgitation measured with 3DTEE and new developed special software.	—

Secondary

Measure	Time frame
Secondary objectives of this study include: investigating the value of different imaging modalities in evaluating periprosthetic regurgitation after TAVI and studying the difference in clinical endpoints according to VARC-2 definitions and quality of life after TAVI between two available aortic valve prostheses.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)