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RECRUITINGOBSERVATIONAL

MYLEAD Spanish Prospective Registry

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult patients (over 18 years of age) - Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve. Who Should NOT Join This Trial: - Patients with pre-existing permanent pacemaker. - Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Adult patients (over 18 years of age) * Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve. Exclusion Criteria: * Patients with pre-existing permanent pacemaker. * Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.

Treatments Being Tested

PROCEDURE

TAVR

TAVR procedure using Myval Transcatheter Heart Valve

Locations (1)

Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain