MYLEAD Spanish Prospective Registry
Key facts
- Where
- Valladolid, SpainSee the site
Where in Spain
- Hospital Clínico Universitario de ValladolidValladolid, SpainContact: Ignacio J. Amat-Santos, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hospital Clínico Universitario de Valladolid
- Trial code
- NCT06917066
- Record updated
- 8 April 2025
- Original description
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.Read full original descriptionShow less
Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)
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.
Inclusion: Adult patients (over 18 years of age); Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.
Exclusion: Patients with pre-existing permanent pacemaker; Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.