Electroporation for Treatment of Atrial Fibrillation

NCT06134752 | Active Not Recruiting

• 1 other identifier: ELECTROAF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation; pulse field ablation; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Freedom from atrial arrhythmias

  12 months

• Intracardiac electrograms analysis

  1 day

• Recording of complications

  30 days

Study Arms (2)

Radiofrequency ablation

ACTIVE COMPARATOR

Pulmonary vein and left atrial posterior wall isolation with point by point radiofrequency ablation.

Other: Radiofrequency ablation

Pulse field ablation

EXPERIMENTAL

Pulmonary vein and left atrial posterior wall isolation with point by point pulse field ablation.

Other: Pulse field ablation

Interventions

Pulse field ablation OTHER

Point by point isolation of pulmonary veins and left atrial posterior wall

Pulse field ablation

Radiofrequency ablation OTHER

Point by point isolation of pulmonary veins and left atrial posterior wall

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Cardiovascular Surgery Department, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Irreversible Electroporation Therapy; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electroporation Therapies; Therapeutics; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jernej Štublar, BSE

  University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)