MYLEAD Spanish Prospective Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TAVR.
- Who it may be relevant to
- Registry conditions: Severe Aortic Valve Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)
Overview
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.
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.
Interventions
- Procedure TAVR
TAVR procedure using Myval Transcatheter Heart Valve
Primary outcome measures
- Presence of rhythm disorders [Time frame: 30 days]
Secondary outcome measures (3)
- Presence of rhythm disorders [Time frame: Postprocedural, 7 days, 1 year]
- Duration of PR interval [Time frame: Postprocedural, 7 days, 30 days, 1 year]
- Duration of QRS complex [Time frame: Postprocedural, 7 days, 30 days, 1 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Clínico Universitario de Valladolid — Valladolid
Identifiers
NCT: NCT06917066 · PS-24-22-C