Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-04 @ 5:37 PM
Study NCT ID:
NCT04054895
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-13', 'mcpReleaseN': 5, 'releaseDate': '2023-08-16'}], 'estimatedResultsFirstSubmitDate': '2023-08-16'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patient will be explained to be randomized to either of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, unicentric, simple blind.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2019-08-07', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular activation time.', 'timeFrame': '45 days', 'description': 'Left ventricular activation time measured by eletrocardiographic imaging.'}], 'secondaryOutcomes': [{'measure': 'QRS duration.', 'timeFrame': 'Implant, 6 months and 12 months.', 'description': 'QRS duration (milliseconds) measured with a 12-lead ECG.'}, {'measure': 'Left ventricular activation time.', 'timeFrame': '6 months and 12 months.', 'description': 'Left ventricular activation time measured by eletrocardiographic imaging'}, {'measure': 'Change in left ventricular function.', 'timeFrame': '6 months and 12 months.', 'description': 'Left ventricular ejection fraction measured with Simpson method with echocardiography.'}, {'measure': 'Change in end-systolic volume.', 'timeFrame': '6 months and 12 months.', 'description': 'End-systolic volume measured with echocardiography.'}, {'measure': 'Change in NYHA functional class.', 'timeFrame': '6 months and 12 months.', 'description': 'NYHA functional class I, II, III, IV.'}, {'measure': 'Hospitalization due to heart failure or mortality (combined endpoint).', 'timeFrame': '1 year.', 'description': 'Hospitalization: patient hospitalization (yes/no) Mortality: mortality (yes/no)'}, {'measure': 'Correction of septal flash', 'timeFrame': '15 days', 'description': 'Correction of septal flash determined with echocardiography (M mode)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Physiological pacing', 'Resynchronization therapy', 'Electrocardiographic imaging'], 'conditions': ['Physiological Pacing', 'Resynchronization Therapy']}, 'referencesModule': {'references': [{'pmid': '37294671', 'type': 'DERIVED', 'citation': 'Pujol-Lopez M, Ferro E, Borras R, Garre P, Guasch E, Jimenez-Arjona R, Garcia-Ribas C, Doltra A, Niebla M, Carro E, Roca-Luque I, Guichard JB, Puente JL, Uribe L, Vazquez-Calvo S, Castel MA, Arbelo E, Porta-Sanchez A, Sitges M, Tolosana JM, Mont L. Stepwise application of ECG and electrogram-based criteria to ensure electrical resynchronization with left bundle branch pacing. Europace. 2023 Jun 2;25(6):euad128. doi: 10.1093/europace/euad128.'}, {'pmid': '36424012', 'type': 'DERIVED', 'citation': 'Pujol-Lopez M, Jimenez-Arjona R, Garre P, Guasch E, Borras R, Doltra A, Ferro E, Garcia-Ribas C, Niebla M, Carro E, Puente JL, Vazquez-Calvo S, Invers-Rubio E, Roca-Luque I, Castel MA, Arbelo E, Sitges M, Brugada J, Tolosana JM, Mont L. Conduction System Pacing vs Biventricular Pacing in Heart Failure and Wide QRS Patients: LEVEL-AT Trial. JACC Clin Electrophysiol. 2022 Nov;8(11):1431-1445. doi: 10.1016/j.jacep.2022.08.001. Epub 2022 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'The LEVEL-AT Trial (LEft VEntricuLar Activation Time Shortening with Physiological Pacing vs Biventricular Resynchronization therapy: a randomized study) is a non-inferiority study that aims to determine if physiological pacing could decrease the left ventricular activation time compared with biventricular therapy.', 'detailedDescription': 'To date studies have showed that physiological pacing could get similar clinical and echocardiographic response to that obtained with biventricular therapy. Activation time shortening with permanent physiological pacing has not been studied.\n\nThis study will randomize 70 patients to a strategy of: biventricular pacing versus physiological pacing.\n\nLEVEL-AT study will analyze the following parameters in the 2 groups: shortening of the QRS, activation time with electrocardiographic imaging, echocardiographic asynchrony and ventricular function and clinical parameters (NYHA functional class, mortality and heart failure hospitalization).\n\nClinical, electrocardiographic, echocardiographic and electrocardiographic imaging follow-up will be performed for 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must indicate their acceptance to participate in the study by signing an informed consent document.\n* The patient must be ≥ 18 years of age.\n* Left bundle branch block, QRS ≥130 and FEVI \\<=35% (Indication of cardiac resynchronization IA or IB ESC Guidelines). No indication of stimulation for AV block.\n* Patients with indication of resynchronization therapy for ventricular dysfunction and indication of cardiac stimulation for AV block according to ESC Guidelines (IA ESC Guidelines).\n* Non-left bundle branch block, QRS ≥150 and FEVI \\<=35% (Indication of cardiac resynchronization IIaB ESC Guidelines).\n\nExclusion Criteria:\n\n* Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.\n* Pregnancy.\n* Participating currently in a clinical investigation that includes an active treatment.'}, 'identificationModule': {'nctId': 'NCT04054895', 'acronym': 'LEVEL-AT', 'briefTitle': 'LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy: a Randomized Study (LEVEL-AT)', 'orgStudyIdInfo': {'id': 'LEVEL-AT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiological pacing', 'description': 'Pacing the his-purkinje system.\n\nCrossover to biventricular CRT will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (\\>3.5V / 1ms); no shortening of QRS (shortening \\<20%) or failure to meet non-selective HBP criteria \\[Europace. 2019 Oct 9. doi: 10.1093/europace/euz275\\].', 'interventionNames': ['Device: Lead placed in the His-Purkinje system in order to achieve QRS shortening.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biventricular resynchronization therapy', 'description': 'Pacing from the right ventricular and coronary sinus leads. Electrocardiographic optimization with fusion-optimized intervals.\n\nCrossover from biventricular CRT to physiological pacing will be allowed in the following situations: coronary sinus cannot be cannulated; no lateral or posterolateral branches; or phrenic stimulation.', 'interventionNames': ['Device: Lead is placed in a tributary of the coronary sinus.']}], 'interventions': [{'name': 'Lead placed in the His-Purkinje system in order to achieve QRS shortening.', 'type': 'DEVICE', 'description': 'Physiologic pacing to achieve QRS shortening. If the patient has indication of stimulation (AV block), a backup lead will be implanted in the right ventricle. All patients will have a lead placed in the right atrium (except those that have permanent atrial fibrillation).', 'armGroupLabels': ['Physiological pacing']}, {'name': 'Lead is placed in a tributary of the coronary sinus.', 'type': 'DEVICE', 'description': 'Biventricular Resynchronization Therapy is the use of a pacemaker with two endocardial leads placed in the right atrium and right ventricle. The third lead is placed in a tributary of the coronary sinus.', 'armGroupLabels': ['Biventricular resynchronization therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Select', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Jose M Tolosana, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}, {'name': 'Margarida Pujol Lopez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}, {'name': 'Lluis Mont Girbau, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Josep Lluis Mont Girbau', 'class': 'OTHER'}, 'collaborators': [{'name': "Institut d'Investigacions Biomèdiques August Pi i Sunyer", 'class': 'OTHER'}, {'name': 'Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Arrhythmia Section. Professor of Cardiology', 'investigatorFullName': 'Josep Lluis Mont Girbau', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}