Status:
RECRUITING
MYLEAD Spanish Prospective Registry
Lead Sponsor:
Hospital Clínico Universitario de Valladolid
Collaborating Sponsors:
Meril Life Sciences Pvt. Ltd.
Conditions:
Severe Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
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,...
Detailed Description
Study Design: Investigator-initiated, prospective, multicentre registry. Study Phase: Phase IV. Study Objectives: 1. To evaluate the incidence of conduction defects and the need of pacemaker implant...
Eligibility Criteria
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.
Key Trial Info
Start Date :
October 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06917066
Start Date
October 23 2024
End Date
December 1 2026
Last Update
April 8 2025
Active Locations (1)
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1
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47003