Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-25 @ 11:41 PM
Study NCT ID:
NCT06917066
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MYLEAD Spanish Prospective Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of rhythm disorders', 'timeFrame': '30 days', 'description': 'Presence of any of the following conduction defects detected in 12-lead ECG:\n\n1. Atrial Fibrillation\n2. Pacemarker\n3. Left bundle branch block\n4. Right bundle branch block\n\n6\\) 1st degree AVB 7) Other conduction disturbances'}], 'secondaryOutcomes': [{'measure': 'Presence of rhythm disorders', 'timeFrame': 'Postprocedural, 7 days, 1 year', 'description': 'Presence of any of the following conduction defects detected in 12-lead ECG:\n\n1. Atrial Fibrillation\n2. Pacemarker\n3. Left bundle branch block\n4. Right bundle branch block\n\n6\\) 1st degree AVB 7) Other conduction disturbances'}, {'measure': 'Duration of PR interval', 'timeFrame': 'Postprocedural, 7 days, 30 days, 1 year', 'description': 'Duration of PR interval (ms) measured in ECG'}, {'measure': 'Duration of QRS complex', 'timeFrame': 'Postprocedural, 7 days, 30 days, 1 year', 'description': 'Duration of QRS complex (ms) measured in ECG'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe Aortic Valve Stenosis', 'TAVR', 'Myval Transcatheter Heart Valve'], 'conditions': ['Severe Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.', 'detailedDescription': 'Study Design: Investigator-initiated, prospective, multicentre registry. Study Phase: Phase IV.\n\nStudy Objectives:\n\n1. 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.\n2. To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve.\n\nDescription of the study protocol:\n\n* 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.\n* TAVR will be performed as per the standard procedure using Myval Transcatheter Heart Valve.\n* The ECG parameters post procedure, at discharge, at 30 days and at 1 year post-procedure will be noted using the REDCAP database.\n* 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.\n* Echocardiogram parameters at 30 days (optional) and at 1 year post procedure will be noted using the REDCAP database.\n* Statistical analysis will be done using IBM SPSS Statistics and R software.\n\nStudy duration:\n\n* 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.\n* In-hospital stage: Postprocedural and predischarge ECGs will be obtained and all the required clinical information will be gathered before discharge.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (over 18 years of age)\n* Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.\n\nExclusion Criteria:\n\n* Patients with pre-existing permanent pacemaker.\n* Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.'}, 'identificationModule': {'nctId': 'NCT06917066', 'acronym': 'MYLEAD', 'briefTitle': 'MYLEAD Spanish Prospective Registry', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clínico Universitario de Valladolid'}, 'officialTitle': 'Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)', 'orgStudyIdInfo': {'id': 'PS-24-22-C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Severe Aortic Valve Stenosis', 'description': 'All patients with Severe Aortic Valve Stenosis undergoing TAVR using Myval Transcatheter Heart Valve', 'interventionNames': ['Procedure: TAVR']}], 'interventions': [{'name': 'TAVR', 'type': 'PROCEDURE', 'description': 'TAVR procedure using Myval Transcatheter Heart Valve', 'armGroupLabels': ['Patients with Severe Aortic Valve Stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47003', 'city': 'Valladolid', 'state': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignacio J. Amat-Santos, PhD', 'role': 'CONTACT', 'email': 'icicor@icicor.es', 'phone': '+34 983420000', 'phoneExt': '86571'}], 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'centralContacts': [{'name': 'Ignacio J Amat-Santos, PhD', 'role': 'CONTACT', 'email': 'icicor@icicor.es', 'phone': '+34 983420000', 'phoneExt': '86571'}, {'name': 'Carlos Baladrón, PhD', 'role': 'CONTACT', 'email': 'icicor@icicor.es', 'phone': '+34 983420000', 'phoneExt': '86571'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clínico Universitario de Valladolid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Meril Life Sciences Pvt. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of Interventional Cardiology Unit', 'investigatorFullName': 'Ignacio J. Amat Santos', 'investigatorAffiliation': 'Hospital Clínico Universitario de Valladolid'}}}}