MYLEAD Spanish Prospective Registry (MYLEAD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Aortic Valve Stenosis
• Intervention / Treatment: Procedure: TAVR

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 implantation post-procedure, at discharge, at 30 days and at 1 year post Myval transcatheter heart valve deployment.
2. To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve.

Description of the study protocol:

• Patients meeting the inclusion and exclusion criteria will be enrolled after taking informed consent. The baseline data and electrocardiogram (ECG), echocardiogram and computed tomography parameters will be added into a dedicated REDCAP database.
• TAVR will be performed as per the standard procedure using Myval Transcatheter Heart Valve.
• The ECG parameters post procedure, at discharge, at 30 days and at 1 year post-procedure will be noted using the REDCAP database.
• Based on these ECG parameters, analysis will be done to look for mean variations of PR and QRS segments, atrio-ventricular block, bundle branch block or need for pacemaker from baseline to post-procedure, at discharge, at 30 days and at 1 year post procedure.
• Echocardiogram parameters at 30 days (optional) and at 1 year post procedure will be noted using the REDCAP database.
• Statistical analysis will be done using IBM SPSS Statistics and R software.

Study duration:

• Inclusion stage: Patients will be recruited during the index procedure; if the patient meets all the inclusion criteria and any exclusion criteria and accepts to participate. ECG, echocardiogram and computed tomography will be done at baseline and the relevant information will be entered into the electronic database.
• In-hospital stage: Postprocedural and predischarge ECGs will be obtained and all the required clinical information will be gathered before discharge.
• Follow up stage: Clinical follow-up will be performed at 30 days and at 1 year post procedure, and the required ECG parameters will be obtained. At the 30-day follow-up, echocardiographic variables will be collected if the centers are available to perform echocardiograms or if an echocardiogram has been performed to the patients for other reasons within the determined period. In the 1-year follow-up, echocardiographic variables collected by clinical practice will be recorded.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Ignacio J Amat-Santos, PhD; Phone Number: 86571 +34 983420000; Email: icicor@icicor.es
• Study Contact Backup: Name: Carlos Baladrón, PhD; Phone Number: 86571 +34 983420000; Email: icicor@icicor.es

Study Locations

• Spain
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clinico Universitario de Valladolid
    • Contact: Ignacio J. Amat-Santos, PhD; Phone Number: 86571 +34 983420000; Email: icicor@icicor.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Severe Aortic Valve Stenosis; All patients with Severe Aortic Valve Stenosis undergoing TAVR using Myval Transcatheter Heart Valve	Procedure: TAVR; TAVR procedure using Myval Transcatheter Heart Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of rhythm disorders	Presence of any of the following conduction defects detected in 12-lead ECG: Atrial Fibrillation; Pacemarker; Left bundle branch block; Right bundle branch block 6) 1st degree AVB 7) Other conduction disturbances	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of rhythm disorders	Presence of any of the following conduction defects detected in 12-lead ECG: Atrial Fibrillation; Pacemarker; Left bundle branch block; Right bundle branch block 6) 1st degree AVB 7) Other conduction disturbances	Postprocedural, 7 days, 1 year
Duration of PR interval	Duration of PR interval (ms) measured in ECG	Postprocedural, 7 days, 30 days, 1 year
Duration of QRS complex	Duration of QRS complex (ms) measured in ECG	Postprocedural, 7 days, 30 days, 1 year

Collaborators and Investigators

• Sponsor: Hospital Clínico Universitario de Valladolid
• Collaborators: Meril Life Sciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Estimated): April 8, 2025

Study Record Updates

• Last Update Posted (Estimated): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: TAVR; Severe Aortic Valve Stenosis; Myval Transcatheter Heart Valve
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: PS-24-22-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No