RecruitingNCT06917066

MYLEAD Spanish Prospective Registry

Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)

Sponsor

Hospital Clínico Universitario de Valladolid

Enrollment

500 participants

Start Date

Oct 23, 2024

Study Type

OBSERVATIONAL

Conditions

Severe Aortic Valve Stenosis

Summary

Investigator-initiated, prospective, multicentre registry, whose objectives are: 1/ to evaluate the incidence of conduction defects and the need of pacemaker implantation post-procedure, at discharge, at 30 days and at 1 year post Myval transcatheter heart valve deployment, and 2/ To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve. Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve that meet all inclusion criteria and any exclusion criteria will be able to participate in this study if they sign the informed consent. Electrocardiogram, echocardiogram and computed tomography will be performed to patients at different time points (Baseline, post-procedure, discharge, 30 days and 1 year post procedure) and their parameters will be added into a dedicated REDCAP database.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Adult patients (over 18 years of age)
Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.

Exclusion Criteria2

Patients with pre-existing permanent pacemaker.
Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.

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