Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-05 @ 8:52 PM
Study NCT ID:
NCT07428967
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients developing pacemaker-induced cardiomyopathy', 'timeFrame': '36 months', 'description': 'Echocardiographically detected deterioration in systolic LVEF of\n\n≥10% to an absolute value of \\< 50%'}], 'secondaryOutcomes': [{'measure': 'Left ventricular function', 'timeFrame': '36 months', 'description': 'Left ventricular ejection fraction (%)'}, {'measure': 'Left Ventricular Global Longitudinal Strain', 'timeFrame': '36 months', 'description': 'Global longitudinal strain of the left ventricle (%)'}, {'measure': 'Right ventricular function', 'timeFrame': '36 months', 'description': 'Tricuspid Annular Plane Systolic Excursion (mm)'}, {'measure': 'Right ventricular function', 'timeFrame': '36 months', 'description': 'Right Ventricle - Pulmonary Artery Coupling (mm/mmHg)'}, {'measure': 'Right ventricular function', 'timeFrame': '36 months', 'description': 'Right ventricular strain (%)'}, {'measure': 'NT-proBNP serum concentration (ng/L)', 'timeFrame': '36 months', 'description': 'NT-proBNP serum concentration (ng/L)'}, {'measure': 'Quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score', 'timeFrame': '36 months', 'description': 'Ranging from 0 to 100 with higher scores represent a better outcome.'}, {'measure': '6-minute walk distance (meters)', 'timeFrame': '36 months'}, {'measure': 'All-cause mortality', 'timeFrame': '36 months'}, {'measure': 'Number of patients with a rehospitalization due to heart failure/cardiac decompensation', 'timeFrame': '36 months'}, {'measure': 'Number of patients with a rehospitalization due to pacemaker malfunction', 'timeFrame': '36 months'}, {'measure': 'Number of patients with a rehospitalization due to atrial arrhythmia', 'timeFrame': '36 months'}, {'measure': 'Number of patients experiencing a stroke or transient ischemic attack', 'timeFrame': '36 months'}, {'measure': 'Procedure-related complications', 'timeFrame': '36 months', 'description': 'Number of patients with one of the following events: death, stroke and TIA; clinically relevant bleeding (Bleeding Academic Research Consortium ≥2) including hematoma at the pacemaker pocket prolonging hospital stay; thrombosis of subclavian/axillary/cubital vein; pneumothorax, pericardial effusion and tamponade; myocardial or septal perforation; coronary vessel injury, including fistula formation; pacemaker lead dislocation or perforation; infection, including pacemaker pocket infection, lead infection, and pacemaker-associated endocarditis; treatment-requiring groin complications such as aneurysm, AV fistula, or dissection (prolonging hospital stay)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Atrial Arrhythmia']}, 'descriptionModule': {'briefSummary': 'AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes.\n\nThe primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy\n2. Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)\n3. AV node ablation scheduled independently of possible study participation\n4. Age ≥ 18 years\n5. Consent capacity\n\nExclusion Criteria:\n\n1. Impaired LVEF (\\< 50%)\n2. Pre-implanted pacemaker\n3. Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)\n4. High grade (III°) left cardiac valvular disease\n5. Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI\n6. Body-mass-index \\> 40 kg/m2\n7. Pregnancy\n8. Inability to give written informed consent\n9. Life expectancy \\< 12 months"}, 'identificationModule': {'nctId': 'NCT07428967', 'acronym': 'AVA CONDUCT', 'briefTitle': 'AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function', 'organization': {'class': 'OTHER', 'fullName': 'St. Josefs-Hospital Wiesbaden GmbH'}, 'officialTitle': 'AtrioVentricular Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AVA CONDUCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Right ventricular pacing', 'interventionNames': ['Procedure: RV pacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Left bundle branch area pacing', 'interventionNames': ['Procedure: LBBA pacing']}], 'interventions': [{'name': 'RV pacing', 'type': 'PROCEDURE', 'description': 'RV apical pacemaker implantation prior to AV node ablation', 'armGroupLabels': ['Right ventricular pacing']}, {'name': 'LBBA pacing', 'type': 'PROCEDURE', 'description': 'LBBA pacemaker implantation prior to AV node ablation', 'armGroupLabels': ['Left bundle branch area pacing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hagen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Harilaos Bogossian, MD', 'role': 'CONTACT'}], 'facility': 'Evangelisches Krankenhaus Hagen-Haspe', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'city': 'Wiesbaden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joachim Ehrlich, MD', 'role': 'CONTACT', 'email': 'jehrlich@joho.de', 'phone': '+496111771200'}, {'name': 'Joachim Ehrlich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andreas Boehmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Josefs-Hospital Wiesbaden GmbH', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Josefs-Hospital Wiesbaden GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}