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Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab

NCT06719921 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 724

Last updated 2026-02-02

No results posted yet for this study

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)

Interventions

PROCEDURE

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.

OTHER

AF ablation in a non-fluoroscopic EP lab

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

OTHER

AF ablation in a fluoroscopic lab

This procedure will take place in a fluoroscopic lab.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2028-04-30
Completion
2028-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719921 on ClinicalTrials.gov