MYLEAD Spanish Prospective Registry

Recruiting now

Conditions studied: Severe Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT06917066

Run by

Hospital Clínico Universitario de Valladolid

People needed

500

Starts

2024-10-23

Expected to finish

2026-12-01

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Hospital Clínico Universitario de Valladolid — Valladolid, Valladolid, Spain (enrolling)

Full record on ClinicalTrials.gov

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