MYLEAD Spanish Prospective Registry

NCT06917066 | Recruiting

• 1 other identifier: PS-24-22-C
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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, 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

Keywords

Severe Aortic Valve Stenosis; TAVR; Myval Transcatheter Heart Valve

Outcome Measures

Primary Outcomes (1)

• Presence of rhythm disorders

  Presence of any of the following conduction defects detected in 12-lead ECG: 1. Atrial Fibrillation 2. Pacemarker 3. Left bundle branch block 4. Right bundle branch block 6\) 1st degree AVB 7) Other conduction disturbances

  30 days

Secondary Outcomes (3)

• Presence of rhythm disorders

  Postprocedural, 7 days, 1 year

• Duration of PR interval

  Postprocedural, 7 days, 30 days, 1 year

• Duration of QRS complex

  Postprocedural, 7 days, 30 days, 1 year

Study Arms (1)

Patients with Severe Aortic Valve Stenosis

All patients with Severe Aortic Valve Stenosis undergoing TAVR using Myval Transcatheter Heart Valve

Procedure: TAVR

Interventions

TAVR PROCEDURE

TAVR procedure using Myval Transcatheter Heart Valve

Patients with Severe Aortic Valve Stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with of Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve who meet all inclusion criteria and any exclusion criteria in 32 centers in Spain.

You may qualify if:

• Adult patients (over 18 years of age)
• Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.

You may not qualify if:

• Patients with pre-existing permanent pacemaker.
• Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead
• Meril Life Sciences Pvt. Ltd.: collaborator

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Ignacio J Amat-Santos, PhD

CONTACT

+34 983420000; icicor@icicor.es

Carlos Baladrón, PhD

CONTACT

+34 983420000; icicor@icicor.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Interventional Cardiology Unit

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 8, 2025
• Study Start: October 23, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)