Spanish Prospective Registry of Myval-Induced Early and Late Conduction Disturbances in Severe Aortic Valve Stenosis

What this Trial Is About

Researchers are conducting a prospective, multicentre registry to study patients with severe aortic valve stenosis who undergo transcatheter aortic valve replacement (TAVR) using the Myval Transcatheter Heart Valve. The study aims to assess the occurrence of heart conduction problems and the need for pacemaker implantation immediately after the procedure, at discharge, 30 days, and one year later. It also seeks to identify factors linked to these conduction defects at different time points. Participants will receive TAVR using the Myval valve following standard procedures. Electrocardiograms (ECG), echocardiograms, and computed tomography scans will be performed at baseline, after the procedure, at discharge, 30 days, and one year post-procedure. Data from these tests will be collected in a dedicated electronic database. Echocardiograms at 30 days are optional depending on center availability or clinical indications. During the study, patients will be monitored with ECGs and echocardiograms at set intervals to evaluate heart rhythm and conduction changes. Researchers will analyze variations in PR and QRS intervals and the presence of blocks or pacemaker requirements. Follow-up visits occur during the hospital stay, at 30 days, and one year after the procedure. Statistical analysis will be performed to better understand conduction disturbances related to the Myval valve deployment.

MYLEAD Spanish Prospective Registry