Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:16 PM
Study NCT ID:
NCT07320560
Status:
RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-25', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-12-25', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedure time', 'timeFrame': 'Day 0', 'description': 'Skin-to-skin duration of the ablation (procedural endpoint)'}, {'measure': 'Total left atrium indwelling time', 'timeFrame': 'Day 0', 'description': 'Procedural endpoint'}, {'measure': 'Fluoroscopy time', 'timeFrame': 'Day 0', 'description': 'Procedural endpoint'}, {'measure': 'Hemolysis marker levels on day 1 post-ablation', 'timeFrame': 'Day 1 post-ablation', 'description': 'Procedural endpoint'}, {'measure': 'GFR on day 1 post-ablation', 'timeFrame': 'Day 1 post-ablation', 'description': 'Procedural endpoint'}, {'measure': 'Proportion of patients with acute renal failure', 'timeFrame': 'Day 0 to 30 post-ablation', 'description': 'Procedural endpoint'}, {'measure': 'hsTroponin on day 1 post-ablation', 'timeFrame': 'Day 1 post-ablation', 'description': 'Procedural endpoint'}], 'primaryOutcomes': [{'measure': 'Rate of acute AF termination', 'timeFrame': 'Procedural', 'description': 'Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with arrhythmia-free survival', 'timeFrame': 'Days 91 to 365 post-ablation', 'description': 'Absence of any atrial tachyarrhythmia (atrial fibrillation \\[AF\\], atrial flutter \\[AFL\\] or atrial tachycardia \\[AT\\]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.'}, {'measure': 'Proportion of patients with AF-free survival', 'timeFrame': 'Days 91 to 365 post-ablation', 'description': 'Absence of atrial fibrillation \\[AF\\] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer.'}, {'measure': 'Time to arrhythmia recurrence', 'timeFrame': 'Days 91 to 365 post-ablation', 'description': 'Time to first atrial tachyarrhythmia (atrial fibrillation \\[AF\\], atrial flutter \\[AFL\\] or atrial tachycardia \\[AT\\]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.'}, {'measure': 'Time to AF recurrence', 'timeFrame': 'Days 91 to 365 post-ablation', 'description': 'Time to first atrial fibrillation \\[AF\\] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer.'}, {'measure': 'Rate of procedure-related complications', 'timeFrame': 'Day 0 to 30 post-ablation', 'description': 'Composite safety endpoint composed of:\n\n* cardiac tamponade requiring drainage\n* persistent phrenic nerve palsy lasting \\>24 hours\n* serious vascular complications requiring intervention\n* stroke/TIA\n* atrioesophageal fistula\n* death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Catheter Ablation', 'Non-invasive mapping', 'Global Mapping', 'Electrocardiographic Imaging', 'Body Surface Mapping', 'Atrial fibrillation drivers'], 'conditions': ['Atrial Fibrillation (AF)']}, 'referencesModule': {'references': [{'pmid': '38636930', 'type': 'BACKGROUND', 'citation': 'Invers-Rubio E, Hernandez-Romero I, Reventos-Presmanes J, Ferro E, Guichard JB, Regany-Closa M, Pellicer-Sendra B, Borras R, Prat-Gonzalez S, Tolosana JM, Porta-Sanchez A, Arbelo E, Guasch E, Sitges M, Brugada J, Guillem MS, Roca-Luque I, Climent AM, Mont L, Althoff TF. Regional conduction velocities determined by noninvasive mapping are associated with arrhythmia-free survival after atrial fibrillation ablation. Heart Rhythm. 2024 Sep;21(9):1570-1580. doi: 10.1016/j.hrthm.2024.04.063. Epub 2024 Apr 16.'}, {'pmid': '40736086', 'type': 'BACKGROUND', 'citation': 'Althoff TF, Anderson RH, Goetz C, Petersen SE, Diaz PM, Nijveldt R, Maurovich-Horvat P, Bax J, Hussain S, Schmidt C, Spicer DE, Sanchez-Quintana D, Corsi C, Dossel O, Climent AM, Rodriguez B, Schotten U, Loewe A, Guillem MS, Cabrera JA, Merino JL, Wijnmaalen AP, Bertrand PB, de Groot N, Derval N, Didenko M, Donal E, Dweck MR, Ho SY. Regionalization of the atria for 3D electroanatomical mapping, cardiac imaging, and computational modelling: a clinical consensus statement of the European Heart Rhythm Association and the European Association of Cardiovascular Imaging of the ESC. Europace. 2025 Jul 1;27(7):euaf134. doi: 10.1093/europace/euaf134.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study investigates if non-invasive global mapping can guide catheter ablation of atrial fibrillation (AF) by defining personalized targets based on the temporal Stability of local Atrial High-Rate Activity (SAHRA). The study also assesses efficacy and safety of this approach and evaluates potential signals of harm. The main questions it aims to answer are:\n\n* Does ablation of targets defined by non-invasive global mapping improve rates of acute atrial fibrillation termination?\n* Does such a personalized ablation approach reduce arrhythmia recurrence rates? Researchers will compare the results of the personalized ablation approach with comparable patients that had undergone a conventional "empirical" ablation approach (pulmonary vein isolation).\n\nParticipants will:\n\n* Undergo a personalized catheter ablation approach employing both a non-invasive global mapping system and a conventional intracardiac mapping system\n* Visit the clinic 3, 6 and 12 months after ablation for clinical follow-up\n* Schedule a telephone visit 9 and 24 months after ablation for clinical follow-up', 'detailedDescription': 'The aim of this study is to test the feasibility and potential of a personalized, non-invasive mapping-guided ablation approach in patients with persistent atrial fibrillation (AF), who are unlikely to benefit from empirical pulmonary vein isolation alone. As a pilot study, it is designed to assess feasibility and procedural efficacy as well as potential signals of harm.\n\nGeneral Strategy:\n\nPatients with persistent AF planned for catheter ablation are eligible in case of left atrial enlargement.\n\nThe study intervention consists of two steps:\n\n1. Empirical pulmonary vein isolation in all patients (current standard of care).\n2. A personalized ablation approach targeting up to three additional atrial regions which harbour critical AF-perpetuating sources:\n\n * Target regions are selected based on the temporal Stability of local Atrial High-Rate Activity (SAHRA) using a non-invasive global mapping system (Acorys, Corify Care).\n * Selected target regions displaying stable high-rate activity are isolated or homogenized according to predefined regional borders based on the 15-segment bi-atrial model of the EHRA and EACVI Clinical Consensus on Standardized Atrial Regionalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAblation-naïve patients with:\n\n1. Persistent AF planned for catheter ablation plus\n2. Left atrial enlargement (LA diameter ≥45 mm or LA volume index ≥35ml/m2 or LA area ≥20 cm2)\n\nExclusion Criteria:\n\n* Previous cardiac ablation\n* Age \\<18 years\n* Pregnancy or lactation\n* Previous stroke/TIA\n* Severe left ventricular dysfunction (LVEF \\<35%)\n* Renal failure (GFR \\<30 ml/min)\n* Dermal disease or hypersensitivity predisposing for skin irritation or exanthema'}, 'identificationModule': {'nctId': 'NCT07320560', 'acronym': 'CURE-AF', 'briefTitle': 'Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping', 'organization': {'class': 'OTHER', 'fullName': 'German Heart Institute'}, 'officialTitle': 'Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping - the CURE-AF Pilot Study', 'orgStudyIdInfo': {'id': 'EA1/204/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-invasive mapping-guided ablation', 'description': 'In this arm patients undergo a personalized ablation approach: In addition to conventional pulmonary vein isolation, additional target regions will be ablated based on non-invasive global mapping.', 'interventionNames': ['Procedure: Non-invasive mapping-guided ablation']}], 'interventions': [{'name': 'Non-invasive mapping-guided ablation', 'type': 'PROCEDURE', 'description': 'The study intervention consists of\n\n1. Empirical pulmonary vein isolation (current standard of care) plus\n2. A personalized ablation approach targeting up to three additional atrial regions which harbour critical AF-perpetuating sources:\n\n * Target regions are selected based on the temporal Stability of local Atrial High-Rate Activity (SAHRA) using a non-invasive global mapping system (Acorys, Corify Care). Local high-rate activity is confirmed by endocardial mapping.\n * Selected target regions displaying stable high-rate activity are isolated or homogenized according to predefined regional borders based on the 15-segment bi-atrial model of the EHRA and EACVI Clinical Consensus on Standardized Atrial Regionalization (Althoff et al. 2025).', 'armGroupLabels': ['Non-invasive mapping-guided ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Till F Althoff, M.D.', 'role': 'CONTACT', 'email': 'till.althoff@dhzc-charite.de', 'phone': '0049 30 450613163'}, {'role': 'CONTACT', 'email': 'till.althoff@dhzc-charite.de'}, {'name': 'Till F Althoff, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'German Heart Center of the Charité, Charité University Hospital Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60598', 'city': 'Frankfurt am Main', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Reza Wakili, M.D.', 'role': 'CONTACT', 'email': 'reza.wakili@herz-frankfurt.de', 'phone': '0049 69 63017404'}, {'role': 'CONTACT', 'email': 'Reza.Wakili@unimedizin-ffm.de'}, {'name': 'Reza Wakili, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Frankfurt University Heart and Vascular Center', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '1169-024', 'city': 'Lisbon', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Mario Martins Oliveira, M.D.', 'role': 'CONTACT', 'email': 'm.martinsoliveira@gmail.com', 'phone': '0035 121 3594000'}, {'name': 'Mario Martins Oliveira, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ivo Roca-Luque, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'iroca@clinic.cat', 'phone': '0034 93 2271778'}, {'name': 'Ivo Roca-Luque, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clinic, University of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Felipe Atienza, M.D.', 'role': 'CONTACT', 'email': 'felipe.atienza@salud.madrid.org', 'phone': '0034 915 86 80 00'}, {'name': 'Felipe Atienza, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gregorio Marañón General University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Till F Althoff, M.D.', 'role': 'CONTACT', 'email': 'till.althoff@dhzc-charite.de', 'phone': '0049 30 450613163'}, {'name': 'Gerhard Hindricks, M.D.', 'role': 'CONTACT', 'email': 'gerhard.hindricks@dhzc-charite.de', 'phone': '030450613163'}], 'overallOfficials': [{'name': 'Till F Althoff, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Heart Center of the Charitè, Berlin, Department of Cardiology, Angiology and Intensive Care Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data underlying published results will be provided upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Heart Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research and Principal Investigator', 'investigatorFullName': 'Till Althoff', 'investigatorAffiliation': 'German Heart Institute'}}}}