Clinical trial Recruiting at 1 site Observational Ages 18 and up

Registry for patients with severe aortic valve stenosis undergoing TAVR with Myval valve

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

Run by Hospital Clínico Universitario de Valladolid · NCT06917066 · Data updated 2026-11-12

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.

More Aortic Valve Stenosis trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorHospital Clínico Universitario de Valladolid
Academic / other
Locations1 site (Valladolid, Valladolid)
StatusRecruiting
StartedOctober 23, 2024
Main results expectedDecember 2025
Study endsDecember 2026
Registry record updatedApril 8, 2025
Trial IDNCT06917066 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old with severe aortic stenosis who are scheduled to undergo TAVR using the Myval valve.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While similar studies have been conducted, this registry focuses specifically on the Myval valve, making it a novel approach in this context.

Who can join: the full rules

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 it's running

  • Hospital Clínico Universitario de Valladolid
    Valladolid, Valladolid, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.