Registry for patients with severe aortic valve stenosis undergoing TAVR with Myval valve
Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)
This study is testing how often heart rhythm problems happen and if patients need a pacemaker after getting a new heart valve through TAVR using the Myval valve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clínico Universitario de Valladolid Academic / other |
| Locations | 1 site (Valladolid, Valladolid) |
| Trial ID | NCT06917066 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicentre registry aimed at evaluating the incidence of conduction defects and the need for pacemaker implantation in patients with severe aortic valve stenosis who undergo transcatheter aortic valve replacement (TAVR) using the Myval Transcatheter Heart Valve. Patients will be monitored at various time points, including discharge, 30 days, and 1 year post-procedure, with assessments including electrocardiograms, echocardiograms, and computed tomography. Data will be collected in a dedicated REDCAP database for statistical analysis to identify factors influencing conduction defects.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with severe aortic stenosis who are scheduled to undergo TAVR using the Myval valve.
Not a fit: Patients with a pre-existing permanent pacemaker or those unable to comply with follow-up assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient outcomes by identifying risk factors for conduction defects and optimizing post-TAVR management.
How similar studies have performed: While similar studies have been conducted, this registry focuses specifically on the Myval valve, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (over 18 years of age) * Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve. Exclusion Criteria: * Patients with pre-existing permanent pacemaker. * Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.
Where this trial is running
Valladolid, Valladolid
- Hospital Clínico Universitario de Valladolid — Valladolid, Valladolid, Spain (Recruiting)
Study contacts
- Study coordinator: Ignacio J Amat-Santos, PhD
- Email: icicor@icicor.es
- Phone: +34 983420000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.