MYLEAD Spanish Prospective Registry
ConditionSevere Aortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Clínico Universitario de Valladolid
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (over 18 years of age)
Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.
Disqualifiers
Patients with pre-existing permanent pacemaker.
Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TAVR
Procedure/SurgeryTAVR procedure using Myval Transcatheter Heart Valve
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Patients with Severe Aortic Valve Stenosis1 intervention
Trial outcomes
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
Time frame
30 daysSecondary 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
Time frame
Postprocedural, 7 days, 1 year2
Duration of PR interval
Duration of PR interval (ms) measured in ECG
Time frame
Postprocedural, 7 days, 30 days, 1 year3
Duration of QRS complex
Duration of QRS complex (ms) measured in ECG
Time frame
Postprocedural, 7 days, 30 days, 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Clínico Universitario de Valladolid
Lead sponsor
Meril Life Sciences Pvt. Ltd.
Collaborator
Source ClinicalTrials.gov