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MYLEAD Spanish Prospective Registry

Study acronym: MYLEAD
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated April 8, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06917066
Lead Sponsor Hospital Clínico Universitario de Valladolid
Collaborators: Meril Life Sciences Pvt. Ltd.
Conditions
(from sponsor)		 Severe Aortic Valve Stenosis
Related terms Aortic Valve Stenosis
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov