EGM Guided PFA for PerAF

NCT06729866 | Active Not Recruiting DMC

• 1 other identifier: EGM-PFA for PerAF
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Pulse field ablation (PFA) has shown safety and efficacy in paroxysmal atrial fibrillation (AF), while the application in persistent atrial fibrillation (PerAF) is still under investigation. The investigators' previous randomized controlled trial showed favorable outcomes with electrogram (EGM) guided radiofrequency ablation in PerAF. However, EGM-guided PFA has not yet been reported.

Conditions

Persistent Atrial Fibrillation

Keywords

eletrogram guided ablation; pulse field ablation; persistent atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• freedom from any AF/AT

  The feasibility primary endpoint was defined as freedom from any AF/AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 3 months, 6 months and 12 months respectively after the procedure.

  freedom from any AF/AT at 3 months, 6 months and 12 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures.

• composite of major safety events

  The safety endpoint is a composite of major safety events including cardiac tamponade or perforation, peripheral or organ thromboembolism, stroke or transient ischemic attack (TIA), diaphragmatic paralysis, block, pericarditis, hemolysis, myocardial infarction, PV stenosis, atrioesophageal fistula, and death. The endpoint includes events occurring within 30 days of the index or reassessment procedures.

  adverse events occurring within 30 days of the index or reassessment procedures.

Secondary Outcomes (2)

• AF recurrence;

  freedom from any AF at 3 months, 6 months and 12 months respectively after the procedure;

• AT recurrence

  freedom from any AT at 3 months, 6 months and 12 months respectively after the procedure;

Study Arms (1)

Electrogram guided pulse field ablation

EXPERIMENTAL

In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.

Procedure: electrogram guided pulse field ablation

Interventions

electrogram guided pulse field ablation PROCEDURE

In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.

Electrogram guided pulse field ablation

Eligibility Criteria

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

You may qualify if:

• Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
• Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent
• ECG-documented episode of persistent AF lasting longer than 7 days
• Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
• Patients who are ≥ 18 years
• Patient participation requirements:
• Is willing and capable of providing Informed Consent to undergo study procedures
• Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

You may not qualify if:

• AF that is:
• Paroxysmal (longest AF episode \< 7days)
• Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
• Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
• Any of the following cardiac conditions:
• Clinically significant arrhythmias other than AF, AFL or AT
• NYHA Class IV CHF
• Atrial or ventricular septal defect closure
• Atrial myxoma
• History of congenital heart disease with any residual anatomic or conduction abnormality
• Any of the following within 3 months of enrollment:
• Myocardial infarction
• Unstable angina
• Percutaneous coronary intervention
• Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)

Sponsors & Collaborators

• Xu Liu: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 11, 2024
• Study Start: September 20, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)