Electroporation for Treatment of Atrial Fibrillation (ELECTROAF)

Electroporation for Treatment of Persistent and Longstanding Persistent Atrial Fibrillation

Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation.

Study Overview

• Status: Active, not recruiting
• Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation
• Intervention / Treatment: Other: Radiofrequency ablation; Other: Pulse field ablation

Detailed Description

Patients with persistent and longstanding persistent atrial fibrillation will be randomized to control and investigational group.

In control group they will receive pulmonary vein and posterior wall ("box lesion") isolation with point by point radiofrequency ablation utilizing the CLOSE protocol with predetermined interlesion distance of up to 6 mm and predetermined ablation index/lesion size index.

In investigational group they will receive pulmonary vein and posterior wall ("box lesion" and additional ablations inside the "box") isolation with point by point pulse field ablation with a predetermined interlesion distance of up to 6 mm and predetermined energy delivery settings.

30 minutes after the last ablation point a high-density mapping of the left atrium will be performed.

Preprocedurally all patients will undergo computer tomography angiography of the left atrium, which will be processed resulting in a three dimensional anatomy reconstruction that will be utilized during the procedures in conjunction with the three dimensional mapping system. Also, left atrial wall thickness will be determined and displayed on the three dimensional anatomy reconstruction.

Before and after radiofrequency and pulse field ablation a five minute bipolar and unipolar intracardiac electrogram recording will be performed at at least two predetermined locations according to wall thickness (at the thinest and at the thickest part of the wall) for later analysis of changes due to different modes of ablation with correlation to lesion durability at a three month re-mapping procedure.

Collection of full blood before and 24 and 48 hours after the procedure to analyse activation of inflammation, coagulation, and also nevral tissue injury and endotelial injury due to ablation. Deviation of markers from the baseline value before the procedure will serve as a measure of activation. Markers analysed: troponin (ng/ml), D dimer (mg/l fibrinogen equivalent units), protein S100 (ng/ml), protein NSE (ng/ml), NT proBNP (pg/ml), high sensitivity CRP (mg/l), interleukin (IL) 6 (pg/ml), procalcitonin (ng/ml), fibrinogen (g/l), P selectin /pg/ml).

Postprocedurally pateints will undergo a remapping procedure three months later to determine pulmonary vein and left atrial posterior wall isolation durability.

Pateints will be followed up with clinical checkup and 1-7 day ECG holters at 3, 6, 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Cardiovascular Surgery Department, University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• atrial fibrillation recorded with 12-lead ECG, holter ECG or implantable device on two occasions at least one week apart

Exclusion Criteria:

• history of previous catheter ablation, history of previous heart surgery, life expectancy less than one year, any lifethreatening severe acute condition, acute deep venous thrombosis, presence of intracardiac masses or thrombi.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiofrequency ablation; Pulmonary vein and left atrial posterior wall isolation with point by point radiofrequency ablation.	Other: Radiofrequency ablation; Point by point isolation of pulmonary veins and left atrial posterior wall
Experimental: Pulse field ablation; Pulmonary vein and left atrial posterior wall isolation with point by point pulse field ablation.	Other: Pulse field ablation; Point by point isolation of pulmonary veins and left atrial posterior wall

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability of isolation	Testing for durability of pulmonary vein and left atrial posterior wall isolation in both study arms with high density endocardial remapping. Absence of electrical activity or voltage inside ablation lines of less than 0.05 mV or presence of exit block upon pacing with local capture will be considered as proof of pulmonary vein and posterior left atrial wall isolation.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from atrial arrhythmias	Freedom from atrial tachycardia, atrial flutter and atrial fibrillation during the follow up as assessed with 12-lead ECG and 1-7 day holter ECG recordings at 3, 6, 12 months. With holter recordings any arrhythmia lasting at least 30 seconds will be considered as a recurrence.	12 months
Intracardiac electrograms analysis	Five minute recording of bipolar and unipolar intracardiac electrograms with a high density mapping catheter at predetermined locations in pulmonary vein antra and left atrial posterior wall before and after radiofrequency and pulse field ablation at the index procedure. Offline analysis of recorded signals and correlation of immediate changes with persistence of durable lesions (isolation) or conduction gaps.	1 day
Recording of complications	Postprocedural endoscopy of the esophagus and endoscopic ultrasound of the esophagus up to 72 hours after the procedure for detection of esophageal injury. Recording of any intra and postprocedural complications up to a 30 day period.	30 days

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Study Chair: Jernej Štublar, BSE, University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: radiofrequency ablation; persistent atrial fibrillation; pulse field ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Surgical Procedures, Operative; Cytological Techniques; Electrochemical Techniques; Ablation Techniques; Radiofrequency Therapy; Electroporation Therapies; Electroporation; Radiofrequency Ablation; Irreversible Electroporation Therapy
• Other Study ID Numbers: ELECTROAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No