MYLEAD Spanish Prospective Registry

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.

NCT Number	NCT06917066
Lead Sponsor	Hospital Clínico Universitario de Valladolid Collaborators: Meril Life Sciences Pvt. Ltd.
Conditions	Severe Aortic Valve Stenosis
Enrollment	500 participants
Start Date	2024-10-23
Primary Completion	2025-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-08