Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05381805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-05-19
First Post:
2022-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ISOLATION 2.0: a Multicenter Clinical Care and Research Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples for analysis of circulating biomarkers of AF Possible biopts of the Left atrium in a subgroup of patients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ablation success', 'timeFrame': '12 months', 'description': 'Freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence of AF or other atrial arrhythmia after the blanking period.', 'timeFrame': '3 to 24 months', 'description': 'Time to recurrence of AF or other atrial arrhythmia after the blanking period of 3 months.'}, {'measure': 'Early recurrences of AF or other atrial arrhythmia', 'timeFrame': '0 to 3 months', 'description': 'Defined as any episode of documented arrhythmia during the blanking period, defined as within 3 months'}, {'measure': 'Number of participants with disease progression to persistent or permanent AF.', 'timeFrame': '0 to 24 months', 'description': "Disease progression to persistent or permanent AF. Persistent AF is defined as AF that lasts longer than 7 days. Permanent AF can't be corrected with treatments."}, {'measure': 'Use of antiarrhythmic drugs (AADs) one year after ablation.', 'timeFrame': '0 to 24 months', 'description': 'Use of antiarrhythmic drugs (AADs) one year after ablation'}, {'measure': 'Interleukin 6 (IL-6) level', 'timeFrame': '0 to 24 months', 'description': 'Change in circulating biomarker for substrate quantification.'}, {'measure': 'Pro-brain natriuretic peptide 2 (pro-BNP2) level', 'timeFrame': '0 to 24 months', 'description': 'Change in circulating biomarker for substrate quantification.'}, {'measure': 'Fibroblast growth factor 23 (FGF-23) level', 'timeFrame': '0 to 24 months', 'description': 'Change in circulating biomarker for substrate quantification.'}, {'measure': 'Dickkopf-related protein 3 (DKK-3) level', 'timeFrame': '0 to 24 months', 'description': 'Change in circulating biomarker for substrate quantification.'}, {'measure': 'Angiopoietin 2 (ANG-2) level', 'timeFrame': '0 to 24 months', 'description': 'Change in circulating biomarker for substrate quantification.'}, {'measure': 'Endothelial cell-specific molecule 1 (ESM-1) level', 'timeFrame': '0 to 24 months', 'description': 'Change in circulating biomarker for substrate quantification.'}, {'measure': 'Insulin-like growth factor-binding protein 7 (IGFBP-7) level', 'timeFrame': '0 to 24 months', 'description': 'Change in circulating biomarker for substrate quantification.'}, {'measure': 'Bone morphogenetic protein 10 (BMP-10) level', 'timeFrame': '0 to 24 months', 'description': 'Change in circulating biomarker for substrate quantification.'}, {'measure': 'Redo procedures', 'timeFrame': '0 to 24 months', 'description': 'Defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal.'}, {'measure': 'Number of veins with pulmonary vein reconnection at redo procedure.', 'timeFrame': '0 to 24 months', 'description': 'Number of veins with pulmonary vein reconnection at redo procedure.'}, {'measure': 'Major adverse cardiovascular events (MACE).', 'timeFrame': '0 to 24 months', 'description': 'Major adverse cardiovascular events (MACE).'}, {'measure': 'Procedure time', 'timeFrame': 'Intraoperative', 'description': 'Defined as skin-to-skin time (time from initial femoral vein puncture to time of removal of sheaths).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ablation', 'Pulmonary Vein Isolation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Treatment recommendations and guidelines for patients with atrial fibrillation (AF) are continuously changing. The role of catheter ablation in the treatment of AF increases and the techniques of the procedures are improving unceasingly. Responding to and evaluating the effect of these changes requires careful examination of this patient population and procedure outcomes. The aim is to create a clinical characterization platform for patients scheduled for AF ablations with the purpose to optimize health care processes and related translational research.', 'detailedDescription': 'Study design: Prospective cohort study and research platform of patients referred for AF ablation. Clinical characteristics and results of routine tests and procedures before, during and after AF ablation are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, and questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from two hospitals in the Netherlands with documented AF, referred for AF ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older;\n* Documented atrial fibrillation;\n* Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Conditions preventing the patient from adhering from the study protocol;\n* Emergency procedures.\n\nA subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:\n\n* Severe allergic reaction against contrast agents used in the CT- or MRI-protocol\n* Severe allergic reaction against body surface electrodes\n\nA subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:\n\n• Status after esophageal or gastric surgery\n\nA subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:\n\n• Contraindication to MRI\n\nA subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:\n\n• Prior catheter or surgical AF ablation.\n\nSpecific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):\n\n* Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;\n* Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;\n* Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.'}, 'identificationModule': {'nctId': 'NCT05381805', 'briefTitle': 'ISOLATION 2.0: a Multicenter Clinical Care and Research Platform', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform', 'orgStudyIdInfo': {'id': 'NL80761.068.22'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zarina Habibi, MD', 'role': 'CONTACT', 'email': 'ablatie.onderzoek@gmail.com', 'phone': '+31-43-3881200'}, {'name': 'Dominique Verhaert, MD', 'role': 'CONTACT', 'email': 'ablatie.onderzoek@gmail.com'}], 'overallOfficials': [{'name': 'Kevin Vernooy, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC+ & Radboudumc'}, {'name': 'Dominik Linz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC+ & Radboudumc & University of Adelaide and Royal Adelaide Hospital & University of Copenhagen'}, {'name': 'Ulrich Schotten, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University & Cardiovascular Research Institute Maastricht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maastricht University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}