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RECRUITING
NCT06917066

MYLEAD Spanish Prospective Registry

Sponsor: Hospital Clínico Universitario de Valladolid

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2024-10-23

Completion Date

2026-12

Last Updated

2025-04-08

Healthy Volunteers

No

Interventions

PROCEDURE

TAVR

TAVR procedure using Myval Transcatheter Heart Valve

Locations (1)

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain