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MYLEAD Spanish Prospective Registry

NCT06917066 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-04-08

No results posted yet for this study

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, 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.

Conditions

  • Severe Aortic Valve Stenosis

Interventions

PROCEDURE

TAVR

TAVR procedure using Myval Transcatheter Heart Valve

Sponsors & Collaborators

  • Meril Life Sciences Pvt. Ltd.

    collaborator INDUSTRY

  • Hospital Clínico Universitario de Valladolid

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917066 on ClinicalTrials.gov