Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab
NCT ID: NCT06719921
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
724 participants
INTERVENTIONAL
2025-04-22
2028-05-31
Brief Summary
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Detailed Description
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Participants are randomized into two groups:
1. Non-Fluoroscopic Lab Group: Ablation procedures will utilize 3D mapping systems. ICE is mandatory for real-time anatomical visualization, and fluoroscopy is employed only in unforeseen procedural challenges to ensure patient safety.
2. Fluoroscopic Lab Group: Procedures are conducted in a fluoroscopic lab using the same tools and mapping system as non-fluoroscopic lab group, with radiation exposure monitored and minimized according to ALARA principles.
The primary efficacy endpoint assesses treatment success at 12 months, defined as freedom from AF, atrial flutter (AFL), or atrial tachycardia (AT) recurrence for more than 30 seconds, as detected by ECG or 7-day Holter. Safety endpoints include a composite of major adverse events such as stroke, tamponade, myocardial infarction, or phrenic nerve injury within 3 months post-procedure. Secondary endpoints focus on procedural metrics, recurrence during the blanking period, adverse event profiles, and changes in quality-of-life forms using the AF Effect on Quality of Life (AFQT) and the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) instruments.
Data collection involves electronic data capture (EDC) systems, with detailed peri-procedural and follow-up evaluations at 3, 6, 9, and 12 months. Each participant undergoes quality-of-life assessments, physical exams, and arrhythmia recurrence monitoring via ECG and 7-day Holter recordings.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Non-Fluoroscopic Lab Group
Ablation procedures will utilize ICE and 3D mapping systems for non-fluoroscopic guidance. ICE is mandatory for real-time anatomical visualization.
AF ablation
The primary ablation strategy for both groups will be pulmonary vein isolation (PVI).
Other additional ablation, including but not limited to linear ablation, complex fractionated atrial electrogram (CFAE) ablation, or superior vena cava (SVC) isolation is not recommended unless necessitated by one of the following:
* Documented atrial flutter (AFL) or atrial tachycardia (AT) observed during the procedure, or
* Arrhythmias originating from the specific region requiring intervention.
AF ablation in a non-fluoroscopic EP lab
This procedure will take place in a non-fluoroscopic lab.
Fluoroscopic Lab Group
Ablation procedures will be conducted in a fluoroscopic lab. The use of ICE, 3D EP mapping systems, and other tools will follow the same recommendations as in the non-fluoroscopic lab group. Radiation exposure will be closely monitored and minimized in accordance with the ALARA (As Low As Reasonably Achievable) principles when necessary.
AF ablation
The primary ablation strategy for both groups will be pulmonary vein isolation (PVI).
Other additional ablation, including but not limited to linear ablation, complex fractionated atrial electrogram (CFAE) ablation, or superior vena cava (SVC) isolation is not recommended unless necessitated by one of the following:
* Documented atrial flutter (AFL) or atrial tachycardia (AT) observed during the procedure, or
* Arrhythmias originating from the specific region requiring intervention.
AF ablation in a fluoroscopic lab
This procedure will take place in a fluoroscopic lab.
Interventions
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AF ablation
The primary ablation strategy for both groups will be pulmonary vein isolation (PVI).
Other additional ablation, including but not limited to linear ablation, complex fractionated atrial electrogram (CFAE) ablation, or superior vena cava (SVC) isolation is not recommended unless necessitated by one of the following:
* Documented atrial flutter (AFL) or atrial tachycardia (AT) observed during the procedure, or
* Arrhythmias originating from the specific region requiring intervention.
AF ablation in a non-fluoroscopic EP lab
This procedure will take place in a non-fluoroscopic lab.
AF ablation in a fluoroscopic lab
This procedure will take place in a fluoroscopic lab.
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed with paroxysmal AF or persistent AF with a duration of 1 years or less, who are referred for catheter ablation.
3. Patients referred for catheter ablation as a first-time intervention (no prior catheter ablation or surgical procedures for AF).
4. The patient is able and willing to provide written informed consent.
Exclusion Criteria
2. Patients with contraindication to right or left sided cardiac catheterization
3. X-ray fluoroscopy is required in the procedure, such as ablation combined with VOM ethanol ablation, epicardial ablation, LAAO, CAG, etc.
4. Serious known concomitant disease with a life expectancy of \< 1 year
5. MI, CABG, or PCI within the preceding 3 months
6. Left atrial diameter \>55 mm
7. LVEF\<30%
8. NYHA class III or IV
9. Awaiting cardiac transplantation or other cardiac surgery within 12 months.
10. History of a documented thromboembolic event within the past 6 weeks.
11. Heart or vascular malformation that impedes catheter access or vascular puncture.
12. Current enrollment in an investigational study evaluating another device or drug.
13. Acute illness, active systemic infection, or sepsis.
14. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
18 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Responsible Party
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Chenyang Jiang
Director of Atrial Fibrillation Center
Locations
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Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Chenyang Jiang, MD, PHD
Role: primary
Other Identifiers
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SRRSH-2025-Research-0052
Identifier Type: -
Identifier Source: org_study_id