Atrial Fibrillation (AF)
Conditions
Keywords
non-fluoroscopic lab, catheter ablation, atrial fibrillation
Brief summary
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.
Detailed description
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: 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. Fluoroscopy-equipped 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.
Interventions
PROCEDUREAF 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.
OTHERAF ablation in a non-fluoroscopic EP lab
This procedure will take place in a non-fluoroscopic lab ( a lab without a fluoroscopy system).
OTHERAF ablation in a fluoroscopic lab
This procedure will take place in a fluoroscopy-equipped lab.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥18 years 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
1. Patients with contraindication to anticoagulation 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation | From enrollment to the end of treatment at 12 months | The primary endpoint of the study is treatment success from the end of the 90-day blanking period through 12 months after the index procedure. Treatment failure is defined as documented AF, atrial flutter, or atrial tachycardia lasting \>30 seconds; continuation or reinitiation of a class I or III AAD after the blanking period; or electrical cardioversion after the blanking period; or repeat catheter ablation for any atrial arrhythmia at any time of follow-up, including during the blanking period. Ablation performed solely for typical right atrial flutter or other supraventricular tachycardia will not constitute treatment failure. |
| Incidence of Composite Procedure-Related Serious Adverse Events at 3 Months Post-Ablation | From enrollment to the end of treatment at 3 months | The primary safety endpoint is a composite of the following prespecified procedure-related serious adverse events: * Major vascular complication or major bleeding within the first 7 days post procedure. * Development of a clinically significant pericardial effusion. * Transient ischemic attack. * Stroke. * Myocardial infarction. * Sinus node dysfunction or high-grade atrioventricular block within 30 days. * Severe pulmonary vein stenosis. * Atrial-esophageal fistula, or phrenic nerve injury within 3 months. * Death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Success of the Procedure | From the start to the completion 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. |
| Proportion of Intra-Procedural Conversion to Using X-ray | From the start to the completion of the procedure. | 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. |
| Proportion of Patients with Recurrence of AF During the First 90 Days Post-Ablation | from the time of ablation to 90 days post-ablation. | he percentage of patients experiencing recurrence of AF or AFL/AT during the blanking period (90 days post-ablation). |
| Incidence of Peri-Procedural Complications | From the start of the procedure to 7 days post-ablation. | The percentage of patients experiencing complications such as cardiac tamponade, stroke, or vascular complications during the peri-procedural period. |
| Total Procedure Duration | During the procedure. | 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). |
| Ablation Time | During the procedure. | The total time during the procedure when energy was delivered for ablation. |
| Change in Quality of Life Using the AF Effect on Quality of Life (AFQT) Instrument | From enrollment to the end of treatment at 12 months | 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. |
| Change in Health-Related Quality of Life Using the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) Instrument | From enrollment to the end of treatment at 12 months | The change in patients' overall health-related quality of life, as measured by the EQ-5D-3L questionnaire. |
Countries
China
Outcome results
None listed