Clinical trial NCT06719921: Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab
Official title: Efficacy and Safety of Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Cardiac Electrophysiology Lab: a Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: non-fluoroscopic lab
catheter ablation
atrial fibrillation
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 724
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: Inclusion Criteria:

1. Age: 18 - 80 years
2. Patients diagnosed with paroxysmal AF or persistent AF with a duration of 3 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.

Primary outcomes:
measure: Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation
timeFrame: From enrollment to the end of treatment at 12 months
measure: Incidence of Composite Procedure-Related Serious Adverse Events at 3 Months Post-Ablation
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
measure: Acute Success of the Procedure
timeFrame: From the start to the completion of the procedure.
measure: Proportion of Intra-Procedural Conversion to Using X-ray
timeFrame: From the start to the completion of the procedure.
measure: Proportion of Patients with Recurrence of AF During the First 90 Days Post-Ablation
timeFrame: from the time of ablation to 90 days post-ablation.
measure: Incidence of Peri-Procedural Complications
timeFrame: From the start of the procedure to 7 days post-ablation.
measure: Total Procedure Duration
timeFrame: During the procedure.
measure: Ablation Time
timeFrame: During the procedure.
measure: Change in Quality of Life Using the AF Effect on Quality of Life (AFQT) Instrument
timeFrame: From enrollment to the end of treatment at 12 months
measure: Change in Health-Related Quality of Life Using the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) Instrument
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
References: