Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial

Status Recruiting

Clinical Trial Summary

This study is a mulitcentre, randomized, parallel-group evaluation of pulse field ablation(PFA) and radiofrequency ablation(RFA) in patients being treated for symptomatic paroxysmal AF. Pulmonary-vein isolation (PVI) is the primary intention of catheter ablation in both groups.

Clinical Trial Description

Patients are randomized to either pulse field ablation(PFA) using the PFA catheters(Insight Medtech) or radiofrequency ablation(RFA) using the RFA catheters（Biosense Webster).During the ablation procedure, the (1:1) randomly selected ablation modality is used in the left atriuablation procedurem to electrically isolate the pulmonary veins (PVs).All investigators demonstrates the success of PVI by the abolition of conduction of atrial impulses into the PVs. Additional LA linear lesions or complex fractionated atrial electrogram ablation(s) are not allowed, and adenosine testing not performed, in either group. Concomitant ablation of previously documented avotricuspid isthmus-dependent atrial flutter (AFL) is allowed at the ablation procedure in both groups. The acute procedural end point is defined as the absence or dissociation of all PV potentials, as confirmed by bi-directional block using a circular mapping catheter after a 20 min waiting period (subsequent to the last ablation). Randomized groups are held throughout the trial, and re-ablation during the 3-month blanking period is allowed if the re-ablation is performing with the same type of catheter used at the ablation procedure. During the 3-month blanking period, antiarrhythmic drug (AAD) administration is allowed, but amiodarone iscontinuation is required at the time of the ablation procedure. Beta-adrenergic blockers is permitted and can be used at any time during this trail. The primary efficacy endpoint is the 12-month treatment success rate，defining as the use of no class I or III AAD and no AF/AFL/AT episodes between the time of ablation blank (within 3 months after the ablation procedure) and 12 months of follow-up. (Confirmed by a definite ECG or dynamic ECG). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06014996
Study type	Interventional
Source	Insight Lifetech Co., Ltd.
Contact	Yumei Xue, PhD
Phone	+86-13570082363
Email	xymgdci@163.com
Status	Recruiting
Phase	N/A
Start date	September 4, 2023
Completion date	December 31, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms