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This randomized controlled trial investigates the efficacy and safety of atrial fibrillation (AF) catheter ablation performed in non-fluoroscopic electrophysiology (EP) labs compared to conventional fluoroscopic digital subtraction angiography labs. The trial hypothesizes non-inferiority in outcomes, with the added benefits of simplified lab environment. Up to 724 participants aged 18-80 with paroxysmal or persistent AF will be enrolled across 10 centers. Participants will be randomized (1:1) to undergo catheter ablation in non-fluoroscopic or fluoroscopic labs, using pulmonary vein isolation (PVI) as the primary ablation strategy. The primary endpoints are freedom from AF recurrence at 12 months and composite safety outcomes related to procedure. Secondary endpoints mainly include procedure duration, recurrence during the initial 90 days, incidence of peri-procedural complications and changes in quality-of-life forms.
This study evaluates the clinical efficacy and safety of AF catheter ablation procedures in non-fluoroscopic EP labs, compared to fluoroscopy labs. Non-fluoroscopic labs rely on advanced technologies such as three-dimensional electroanatomic mapping system, intracardiac echocardiography (ICE), contact force sensing catheter and/or pulsed field ablation(PFA), etc...
Participants are randomized into two groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Fluoroscopic Lab Group | Experimental | Ablation procedures will utilize ICE and 3D mapping systems for non-fluoroscopic guidance. ICE is mandatory for real-time anatomical visualization. |
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| Fluoroscopic Lab Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AF ablation | Procedure | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation | The primary end point of the study is freedom from any documented atrial arrhythmia, including AF, atrial tachycardia or atrial flutter episodes lasting longer than 30 seconds without antiarrhythmic drugs, for 12 months after the index ablation procedure, excluding a 3-month blanking period. The continuation or reinitiation of class I or class III antiarrhythmic drugs after the 3-month post-ablation blanking period, as well as electric cardioversion or catheter ablation for any atrial arrhythmias, are considered treatment failures for the primary end point. | From enrollment to the end of treatment at 12 months |
| Incidence of Composite Procedure-Related Serious Adverse Events at 3 Months Post-Ablation | The primary safety endpoint is a composite of the following prespecified procedure-related serious adverse events:
| From enrollment to the end of treatment at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Success of the Procedure | The acute success of the procedure is defined as the percentage of procedures achieving the intended acute procedural endpoints, including: 1) Complete PVI, as confirmed by mapping or pacing maneuvers. 2) Immediate restoration and maintenance of sinus rhythm at the end of the procedure, either spontaneously or through cardioversion. | From the start to the completion of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Sub-analysis 1: Analysis of PFA VS RFA | Analysis of the primary and secondary endpoints separately for RFA and PFA. All analyses will be conducted post hoc within the predefined data structure of the parent trial. No additional procedures, study visits, or participant consent are required, as this analysis relies solely on data collected as part of routine protocol-mandated assessments. | From enrollment to the end of treatment at 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310000 | China |
The IPD collected during this study will not be made publicly available. The decision not to share IPD is based on lack of resources to support secure and compliant data sharing. The study's findings are fully presented in the manuscript, and any additional summary data can be provided upon reasonable request to the corresponding author, subject to ethical considerations and institutional policies.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2025 | Jan 27, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| AF ablation in a non-fluoroscopic EP lab | Other | This procedure will take place in a non-fluoroscopic lab. |
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| AF ablation in a fluoroscopic lab | Other | This procedure will take place in a fluoroscopic lab. |
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| Proportion of Intra-Procedural Conversion to Using X-ray | The percentage of procedures in each group (non-fluoroscopic and conventional DSA lab) that required conversion to X-ray guidance during the ablation procedure. Conversion is defined as the use of fluoroscopy to complete any part of the procedure that could not be accomplished using the assigned guidance modality. | From the start to the completion of the procedure. |
| Proportion of Patients with Recurrence of AF During the First 90 Days Post-Ablation | he percentage of patients experiencing recurrence of AF or AFL/AT during the blanking period (90 days post-ablation). | from the time of ablation to 90 days post-ablation. |
| Incidence of Peri-Procedural Complications | The percentage of patients experiencing complications such as cardiac tamponade, stroke, or vascular complications during the peri-procedural period. | From the start of the procedure to 7 days post-ablation. |
| Total Procedure Duration | The total time elapsed from the moment of skin puncture to the removal of all catheters and completion of the procedure (skin-to-skin time). | During the procedure. |
| Ablation Time | The total time during the procedure when energy was delivered for ablation. | During the procedure. |
| Change in Quality of Life Using the AF Effect on Quality of Life (AFQT) Instrument | The change in patients' self-reported quality of life related to atrial fibrillation, as measured by the AF Effect on Quality of Life (AFQT) questionnaire. And the change in patients' overall health-related quality of life, as measured by the EQ-5D-3L questionnaire. | From enrollment to the end of treatment at 12 months |
| Change in Health-Related Quality of Life Using the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) Instrument | The change in patients' overall health-related quality of life, as measured by the EQ-5D-3L questionnaire. | From enrollment to the end of treatment at 12 months |
| Sub-analysis 2: Impact of blanking period definitions following PFA | This sub-analysis will explore the effect of different blanking period definitions (1-month, 2-month vs 3-month) on arrhythmia-free success rates after PFA, using the same dataset and follow-up schedule as the main study. It is an exploratory analytical component of the main trial and does not involve separate randomization or data collection. | From enrollment to the end of treatment at 12 months |
| Sub-analysis 3: Impact of AF duration and symptom/diagnosis-to-ablation interval on ablation success | This sub-analysis will explore whether different time definitions influence the interpretation of 12-month ablation success. Two analytical models will be applied using the main trial dataset without additional interventions or visits:
This exploratory sub-analysis compares analytical approaches only; it does not modify clinical management, affect randomization, or add data collection requirements. | From enrollment to the end of treatment at 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |