Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05006456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-12-20
First Post:
2021-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-world Experience of Catheter Ablation Using Novel Ablation Technologies for the Treatment of Atrial Fibrillation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-06', 'studyFirstSubmitDate': '2021-07-14', 'studyFirstSubmitQcDate': '2021-08-08', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent of subjects who are freedom from atrial arrhythmia (any documented AF, atrial tachycardia (AT), or atrial flutter (AFL) episode.', 'timeFrame': '12 months', 'description': 'percent of subjects who are freedom from atrial arrhythmia (any documented AF, atrial tachycardia (AT), or atrial flutter (AFL) episode of ≥30 seconds by heart rhythm monitoring patch, ECG, or Holter recording) from days 91 to 365 post ablation, with or without the use of any anti-arrhythmic drugs (AADs).'}, {'measure': 'Incidence of primary adverse events (PAEs)', 'timeFrame': '7 days', 'description': 'PAEs defined as procedure- or device-related serious adverse events occurred within 7 days of the procedure'}], 'secondaryOutcomes': [{'measure': 'AF recurrence', 'timeFrame': '12 month', 'description': 'Freedom from documented AF/AT/ AFL lasting≥30 seconds recording post ablation from days 91 to 365 without AADs, monitoring with ECG; Holter; Heart Rhythm Monitoring Patch;Dual/ CRT Pacer or ICD.'}, {'measure': 'Acute procedural success of PVI', 'timeFrame': 'During ablation procedure', 'description': 'Acute procedural success of PVI, confirmed by entrance block in all pulmonary veins after adenosine and/or isoproterenol challenge'}, {'measure': 'First pass isolation rate', 'timeFrame': 'During ablation procedure', 'description': 'First pass isolation rate for STSF/QDOT before adenosine/isoproterenol challenge'}, {'measure': 'Single-Shot-Success (SSS) rate', 'timeFrame': 'During ablation procedure', 'description': 'Single-Shot-Success (SSS) rate for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge'}, {'measure': 'Time to isolation (TTI)', 'timeFrame': 'During ablation procedure', 'description': 'Time to isolation (TTI) for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge'}, {'measure': 'Proportion of acute pulmonary vein (PV) reconnection', 'timeFrame': 'During ablation procedure', 'description': 'Proportion of acute pulmonary vein (PV) reconnection, with number and location of any gaps in each patient'}, {'measure': 'Procedure time', 'timeFrame': 'During ablation procedure', 'description': 'Including total procedure time，LA time，RF application time per circle ，needle time in transseptal puncture'}, {'measure': 'Mapping points', 'timeFrame': 'During ablation procedure', 'description': 'mapping points'}, {'measure': 'fluid volume', 'timeFrame': 'During ablation procedure', 'description': 'fluid volume delivered via catheter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paroxysmal Atrial Fibrillation', 'Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this registry is to obtain real-world clinical experience for the latest and future ablation technologies when used in conjunction with the Carto system in the treatment of patients with atrial fibrillation (AF) in Asian countries. The ablation technologies include THERMOCOOL SMARTTOUCH® SF (STSF) catheter with Ablation Index (AI) /Visitag SURPOINT, QDOT catheter, and HELIOSTAR catheter. Additional new ablation and/or mapping technologies may be included in future when they become available in local markets.', 'detailedDescription': 'Novel-AF study is a prospective, non-randomized, multi-center, longitudinal study.\n\n1. Primary endpoint 1.1 The primary effectiveness endpoint is the percent of subjects who are freedom from atrial arrhythmia (any documented AF, atrial tachycardia (AT), or atrial flutter (AFL) episode of ≥30 seconds by heart rhythm monitoring patch, ECG, or Holter recording) from days 91 to 365 post ablation, with or without the use of any anti-arrhythmic drugs (AADs).\n\n 1.2 The primary safety endpoint is the incidence of primary adverse events (PAEs), defined as procedure- or device-related serious adverse events occurred within 7 days of the procedure.\n2. Secondary endpoint 2.1 Freedom from documented AF/AT/ AFL lasting≥30 seconds from days 91 to 365 post ablation without AADs 2.2 Acute procedural success of PVI, confirmed by entrance block in all pulmonary veins after adenosine and/or isoproterenol challenge 2.3 First pass isolation rate for STSF/QDOT and Single-Shot-Success (SSS) rate for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge 2.4 Time to isolation (TTI) for HELIOSTAR per PV/ per patient before adenosine/isoproterenol challenge 2.5 Numbers of acute pulmonary vein (PV) reconnection after waiting/challenge, with number and location of any gaps in each patient 2.6 Procedural efficiency parameters \\[total procedure time, mapping time and points, LA time, fluoroscopy time and dose, RF application time per circle (left and right wide area circumferential ablation) and in total, needle time in transseptal puncture, and fluid volume delivered via catheter\\]\n3. Follow up Follow-up visits will be scheduled at 3, 6, 9 and 12 months after the index ablation procedure 3.1 Subject baseline information: age, sex, height, weight, medical and heart surgery history, left ventricular ejection fraction (LVEF), left atrial dimension, left atrium volume, New York Heart Association (NYHA) Class, physical activity (IPAQ-S-CBaecke et al), depression (PHQ-9) and anxiety (PHQ-GAD-7), AF symptoms/duration, quality of life (AFEQT/EQ-5D), concomitant medications, LAA detection methods (CT/TEE/ICE), and results of laboratory tests 3.2 Peri-procedural data :\n\n * Procedural and ablation data: total procedure time, LA time, fluoroscopy time and dose, RF application time per circle\n * Ablation strategies: Ablation sites and the AI values for each ablation line\n * Acute success data\n * VISITAG® source database\n * Postprocedural complications/adverse events: device- and/or procedure-related serious adverse events (SAEs\\]\n * Periprocedural medications: anticoagulants, AADs, and sedation medicine\n * Duration of hospital stay. 3.3 Follow-up data\n * Patient information（details）\n * Concomitant medications\n * Any documented AF recurrence in 12-lead ECG, Holter, or any qualified monitoring equipment.\n * Re-ablation and ablation sites (if applicable)\n * Emergency room visit or hospitalization due to arrhythmia recurrence or procedure-related complications\n * New onset medical conditions\n * Adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Signed informed consent to participate in the study\n* Drug refractory symptomatic paroxysmal AF or symptomatic persistent AF for less than 12 months who, in the opinion of the investigator, are candidates for catheter ablation per standard-of-care\n* Undergoing AF ablation for the first time\n* THERMOCOOL SMARTTOUCH® SF catheter with Visitag SURPOINT or newer technologies (e.g. QDOT, HELIOSTAR) are used in conjunction with Carto system in the ablation procedure\n\nExclusion Criteria:\n\n* Women of childbearing potential who are, or plan to become, pregnant during the time of the study\n* The subject has a life expectancy of less than 12 months\n* Severe valvular heart disease\n* The subject has been enrolled in another investigational study evaluating a medical device or a drug.'}, 'identificationModule': {'nctId': 'NCT05006456', 'acronym': 'NOVEL AF', 'briefTitle': 'Real-world Experience of Catheter Ablation Using Novel Ablation Technologies for the Treatment of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Real-world Experience of Catheter Ablation Using Novel Ablation Technologies Associated With the Carto System for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (NOVEL AF)', 'orgStudyIdInfo': {'id': '2021-novel'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Cohort 1 consists of 2000 subjects undergoing catheter ablation with STSF catheter, in which AI is used to guide the ablation lesion creation.', 'interventionNames': ['Device: Catheter ablation']}, {'label': 'Cohort 2', 'description': 'Cohort 2 consists of 2000 subjects who undergoing catheter ablation using QDOT or HELIOSTAR catheter.', 'interventionNames': ['Device: Catheter ablation']}], 'interventions': [{'name': 'Catheter ablation', 'type': 'DEVICE', 'description': 'Subjects will undergo catheter ablation using the new technologies, including THERMOCOOL SMARTTOUCH® SF catheter with Visitag SURPOINT, QDOT catheter and HELIOSTAR catheter when they are used in conjunction with Carto system for AF ablations.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xin Du, MD, PhD', 'role': 'CONTACT', 'email': 'duxinheart@sina.com', 'phone': '086-010-84005363'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart Health Research Center', 'class': 'OTHER'}, {'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Chang sheng Ma', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}