Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-01 @ 8:41 PM
Study NCT ID:
NCT04065893
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2019-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D018879', 'term': 'Ventricular Premature Complexes'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2019-08-16', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Biventricular pacing', 'timeFrame': '3 month after intervention biventricular pacing (%) is routinely monitored', 'description': 'Influence of intervention (Ablation/medical treatment) on previously reduced biventricular pacing percentage (\\<98%). Biventricular pacing is measured in percentage of stimulation and is monitored at routine device interrogation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systolic Heart Failure', 'Ventricular Premature Complexes', 'Ventricular Tachycardia', 'Cardiac Resynchronization Therapy', 'Reduced Biventricular Pacing']}, 'referencesModule': {'references': [{'pmid': '35697890', 'type': 'DERIVED', 'citation': 'van den Bruck JH, Middeldorp M, Sultan A, Scheurlen C, Seuthe K, Wormann J, Filipovic K, Kadhim K, Sanders P, Steven D, Luker J. Impact of ventricular arrhythmia management on suboptimal biventricular pacing in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2023 Mar;66(2):353-361. doi: 10.1007/s10840-022-01259-0. Epub 2022 Jun 14.'}]}, 'descriptionModule': {'briefSummary': "Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%.\n\nReduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pts. with systolic heart failure, wide QRS complex and CRT with reduced biventricular pacing due to ventricular arrhythmia (PVC/VT)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* reduced biventricular pacing \\<98% due to ventricular arrhythmia\n\nExclusion Criteria:\n\n* reduced biventricular pacing \\<98% due to other cause\n* age \\<18\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04065893', 'briefTitle': 'Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Köln'}, 'officialTitle': 'Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy', 'orgStudyIdInfo': {'id': 'CRT-Bivent.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Catheter ablation group', 'description': 'Patients with reduced biventricular pacing due to PVC or VT receiving catheter ablation of PVC/VT according to guidelines and clinical practices', 'interventionNames': ['Procedure: Catheter ablation of ventricular arrhythmia']}, {'label': 'Medical treatment group', 'description': 'Patients with reduced biventricular pacing due to PVC or VT receiving intensified medical therapy (antiarrhythmics/betablocker) according to guidelines and clinical practices', 'interventionNames': ['Drug: Intensified medical therapy']}], 'interventions': [{'name': 'Catheter ablation of ventricular arrhythmia', 'type': 'PROCEDURE', 'description': 'PVC or VT ablation', 'armGroupLabels': ['Catheter ablation group']}, {'name': 'Intensified medical therapy', 'type': 'DRUG', 'description': 'Dosage increase / new onset of Betablocker / medical antiarrhythmic medication according to guideline and clinical practice', 'armGroupLabels': ['Medical treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Köln', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}