Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab

NCT06719921 | Enrolling By Invitation DMC

• 1 other identifier: SRRSH-2025-Research-0052
• Study Type: interventional
• Target: 724
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Keywords

non-fluoroscopic lab; catheter ablation; atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• 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: * 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.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (8)

• Acute Success of the Procedure

  From the start to the completion of the procedure.

• Proportion of Intra-Procedural Conversion to Using X-ray

  From the start to the completion of the procedure.

• Proportion of Patients with Recurrence of AF During the First 90 Days Post-Ablation

  from the time of ablation to 90 days post-ablation.

• Incidence of Peri-Procedural Complications

  From the start of the procedure to 7 days post-ablation.

• Total Procedure Duration

  During the procedure.

Other Outcomes (3)

• Sub-analysis 1: Analysis of PFA VS RFA

  From enrollment to the end of treatment at 12 months

• Sub-analysis 2: Impact of blanking period definitions following PFA

  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

  From enrollment to the end of treatment at 12 months

Study Arms (2)

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.

Procedure: AF ablation; Other: AF ablation in a non-fluoroscopic EP lab

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.

Procedure: AF ablation; Other: AF ablation in a fluoroscopic lab

Interventions

AF ablation in a fluoroscopic lab OTHER

This procedure will take place in a fluoroscopic lab.

Fluoroscopic Lab Group

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: * Documented atrial flutter (AFL) or atrial tachycardia (AT) observed during the procedure, or * Arrhythmias originating from the specific region requiring intervention.

Fluoroscopic Lab Group; Non-Fluoroscopic Lab Group

AF ablation in a non-fluoroscopic EP lab OTHER

This procedure will take place in a non-fluoroscopic lab.

Non-Fluoroscopic Lab Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years
• Patients diagnosed with paroxysmal AF or persistent AF with a duration of 1 years or less, who are referred for catheter ablation.
• Patients referred for catheter ablation as a first-time intervention (no prior catheter ablation or surgical procedures for AF).
• The patient is able and willing to provide written informed consent.

You may not qualify if:

• Patients with contraindication to anticoagulation
• Patients with contraindication to right or left sided cardiac catheterization
• X-ray fluoroscopy is required in the procedure, such as ablation combined with VOM ethanol ablation, epicardial ablation, LAAO, CAG, etc.
• Serious known concomitant disease with a life expectancy of \< 1 year
• MI, CABG, or PCI within the preceding 3 months
• Left atrial diameter \>55 mm
• LVEF\<30%
• NYHA class III or IV
• Awaiting cardiac transplantation or other cardiac surgery within 12 months.
• History of a documented thromboembolic event within the past 6 weeks.
• Heart or vascular malformation that impedes catheter access or vascular puncture.
• Current enrollment in an investigational study evaluating another device or drug.
• Acute illness, active systemic infection, or sepsis.
• Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Atrial Fibrillation Center

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 6, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)