[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-flutter-typical\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-flutter-typical":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,71,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100414564","zero-fluoroscopy-voltage-guided-vs-linear-cti-ablation-100414564",false,"NCT04678258","Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation","A Zero Fluoroscopy Maximum Voltage Guided Stepwise Approach Using IntellaMiFi Technology Compared to Linear Ablation of the Cavotricuspid Isthmus for Typical Atrial Flutter: the ZERO MAGIC Trial","ZERO MAGIC","Inclusion Criteria:\n\n* Typical (CTI dependent) atrial flutter documented in a standard 12 lead surface ECG\n* Given class I indication for curative CTI ablation according to the current guidelines\n* Over 18 years old\n* Given informed consent\n\nExclusion Criteria:\n\n* Any contraindication for CTI ablation\n* Previous CTI ablation\n* BCB as procedural endpoint not assessable\n* CTI ablation conducted in association with further ablation procedures\n* Patients with CIED (e.g. pacemaker, ICD)\n* Tricuspid valve replacement\n* Right atrial thrombus\n* Pregnant or breastfeeding women\n* Abuse of drugs or alcohol\n* Age \\\u003C 18 years\n* Incompliance to the treatment, e.g. necessary anticoagulation\n* Expected survival less than one year\n* Inability to understand the nature and rationale of the study\n* Inability to take part in the follow up","ALL","18 Years",{"count":20,"type":21},106,"ESTIMATED","INTERVENTIONAL",[24],"NA","Catheter ablation of the cavo-tricuspid isthmus (CTI) is the curative first-line therapy for typical atrial flutter. Currently, two approaches are used in clinical practice. In contrast to the conventional linear ablation approach, the Maximum voltage-guided (MVG) strategy aims to limit ablation to high voltage areas (HVAs) representing the detectable correlate of relevant conducting bundles. Data from registries show that the MVG technique is sufficient to reach comparable clinical outcome with significantly shorter ablation duration when compared to the conventional linear strategy.\n\nDespite growing evidence, however, data from properly powered prospective randomized trials are lacking and the linear approach still remains standard. In addition, data on radiation exposure are controversial.\n\nAs a substrate-based approach, the MVG strategy requires detailed mapping and signal analysis for identification of the individual architecture and exactly targeted energy application. However, the spatial mapping resolution of large tip catheters is limited. The use of the MicroFidelity catheter technology (IntellaMiFi) with high resolution mini-electrodes at the 8 mm catheter tip can be expected to further improve the feasibility of a voltage-guided approach. In addition, the MVG approach theoretically may encompass an increased risk for clinically inapparent reconduction. A prospective study with predefined invasive re-evaluation of persistent CTI block is needed to further evaluate this issue.\n\nObjective of this prospective randomized study is evaluate the performance of the micro-sensor technology for zero-fluoroscopy voltage-guided ablation of typical atrial flutter (AFL) compared with a population undergoing conventional linear ablation including a predefined invasive re-evaluation of persistent CTI block in addition to clinical follow-up.\n\nThe study has been approved by the responsible ethics committee.",[27,28,29],"Catheter Ablation","Atrial Flutter Typical","Radiation Exposure",[31,32,33],"atrial flutter typical","catheter ablation","electroanatomic mapping","RECRUITING","2026-06-12",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":38},"2020-11-30",{"date":42,"type":21},"2027-08-31",{"name":44,"class":45},"Klinikum-Fuerth","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100642672","prophylactic-pulmonary-vein-isolation-during-atrial-flutter-ablation-100642672","NCT07649603","Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation","Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation: The PREVENT-AF Study II","PREVENT-AF II","Inclusion Criteria:\n\n1. Age ≥ 55 years on date of consent\n2. History of typical AFL and plans for a guideline-supported catheter ablation for AFL - including paroxysmal AFL defined as AFL with duration of up to 7 days and persistent AFL as longer than 7 days or if interrupted by cardioversion for clinical reasons and up to 1 year\n3. Left atrial diameter ≥ 4.5 cm within 12 calendar months prior to or on consent date by transthoracic echocardiography\n4. No identifiable AF on any prior ECG within past 1 year\n5. CHA2DS2 -VASc ≥ 2\n\nExclusion Criteria:\n\n1. Inability to undergo or AFL or AF catheter ablation (e.g., presence of a left atrial thrombus)\n2. AFL or AF due to reversible cause e.g. hyperthyroid state\n3. Contraindication to systemic anticoagulation\n4. Prior surgical or percutaneous cardiac ablation procedure any time in the past\n5. Prior AFL ablation (e.g. CTI) or PVI ablation any time in the past\n6. LV ejection fraction \\\u003C 35%\n7. Paroxysmal, persistent or longstanding persistent AF\n8. Presence of NYHA Class IV congestive heart failure\n9. Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and\u002For stent angioplasty) within 3 calendar months prior to consent date\n10. Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent\n11. Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair\u002Freplacement procedures\n12. Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date\n13. Any medical condition likely to limit survival to \\\u003C 1 year\n14. Renal failure requiring dialysis at time of consent\n15. Pregnancy\n16. History of non-compliance to medical therapy\n17. Participation in other clinical trials (observational\u002Flead registries are allowed) without approval from the DCC\n18. Inability or unwillingness to provide informed consent\n19. Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult\n20. Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial","55 Years",{"count":57,"type":21},620,[24],"Pulmonary vein isolation (PVI) via catheter ablation has been successfully employed for years to treat symptomatic atrial fibrillation (AF). Moreover, PVI has not been used as a prophylactic intervention even in groups known to be high-risk for the future development of AF. Preliminary studies, including our pilot PREVENT AF I randomized trial, suggested that prophylactic PVI may be effective at reducing new onset AF and overall AF burden in atrial flutter (AFL) patients.\n\nThis is a multicenter single-blind randomized controlled trial, \"Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation\" (PREVENT AF II) to determine if PVI in conjunction with AFL ablation for patients with typical AFL results in a significant reduction in cardiac events and healthcare utilization.",[28],"NOT_YET_RECRUITING","2026-06-09",{"date":64,"type":38},"2026-06-16",{"date":66,"type":21},"2027-06",{"date":68,"type":21},"2032-05",{"name":70,"class":45},"University of Rochester",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100508755","atrial-flutter-ablation-in-the-icmr-100508755","NCT05904548","Atrial Flutter Ablation in the iCMR","Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter","VISABL-AFL","Inclusion Criteria:\n\n* Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment\n* Patient 18 years and older\n\nExclusion Criteria:\n\n* Contraindications for MRI procedures\n* Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure\n* Previous CTI ablation procedures\n* Myocardial infarction within 60 days of enrollment\n* Current unstable angina\n* Cardiac surgery within 90 days of enrollment\n* Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment\n* Thrombocytosis or thrombocytopenia\n* Contraindication to anticoagulation therapy\n* Currently documented intracardiac thrombus or myxoma\n* Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment\n* Prosthetic valve through which the catheter must pass\n* Interatrial baffle or patch through which the catheter must pass\n* Moderate or severe tricuspid valve regurgitation or stenosis\n* Uncompensated congestive heart failure\n* Active systemic infection\n* Pregnancy or if subject plans to become pregnant during the trial\n* Uncontrolled hyperthyroidism\n* Any other significant uncontrolled or unstable medical condition\n* Enrollment in any concurrent study without Imricor written approval\n* Life expectancy of less than or equal to 2 years (730 days) per physician opinion",{"count":80,"type":21},91,[24],"The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.",[28],[85,86],"RF Ablation","interventional Cardiac Magnetic Resonance (iCMR)","2026-04-08",{"date":89,"type":38},"2026-04-13",{"date":91,"type":38},"2024-06-20",{"date":93,"type":21},"2026-12-31",{"name":95,"class":96},"Imricor Medical Systems","INDUSTRY",6,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100578911","pulmonary-vein-isolation-in-typical-atrial-flutter-and-heart-failure-100578911","NCT06817447","Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure","Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study","PVI-AFL-HF","Inclusion Criteria:\n\n* Aged 18 to 80 years\n* Typical AFL referring for ablation\n* No prior history of AF\n* Fulfilling the criteria for HF: New York Heart Association (NYHA) function class II or greater; and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) \\>125 pg\u002Fml in sinus rhythm or \\>365 pg\u002Fml in AFL\n* Optimized guideline-directed medical therapy for HF for at least one month\n* A minimum of anticoagulation for three weeks\n* Sign informed consent\n\nExclusion Criteria:\n\n* Any AF episodes documented during 48-hour Holter monitoring\n* Presence of left atrial thrombus\n* HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease\n* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment\n* Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease\n* Untreated hypothyroidism or hyperthyroidism\n* Dialysis-dependent terminal renal failure\n* Life expectancy \\\u003C12 months due to non-cardiovascular causes.\n* Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study\n* Female under pregnancy or breast-feeding\n* Involved in other studies","80 Years",{"count":108,"type":21},168,[24],"This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.",[28,112],"Heart Failure",[114,115,116],"atrial flutter","Heart failure","Pulmonary vein isolation","2025-02-05",{"date":119,"type":38},"2025-02-10",{"date":121,"type":21},"2025-03-01",{"date":123,"type":21},"2029-03-01",{"name":125,"class":45},"The First Affiliated Hospital with Nanjing Medical University"]