Catheter Ablation of Advanced Forms of Atrial Fibrillation

NCT07446244 | Active Not Recruiting

• 1 other identifier: 145780304
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate feasibility, safety, and efficacy of pulmonary vein isolation combined with posterior left atrial isolation and multiple linear lesions in both atria in patients with persistent and long-standing persistent atrial fibrillation.

Conditions

Persistent Atrial Fibrillation; Persistent Atrial Fibrillation Longstanding

Keywords

pulsed field ablation; atrial fibrillation; cox maze

Outcome Measures

Primary Outcomes (1)

• Atrial arrhythmia recurrence

  Atrial fibrillation/atrial tachycardia/atrial undulation lasting more than 30s after 8 week blanking period and without antiarrhythmic drug therapy. Assessed with 7-day Holter ECG at 3, 6, 12 months after index procedure.

  12 months

Secondary Outcomes (4)

• Efficacy of endovascular Cox maze procedure

  12 month

• Interventions

  12 months

• Durability of ablation lines and isolations

  3 months

• Safety of catheter ablation procedure

  6 months

Study Arms (1)

Cohort

EXPERIMENTAL

Long-standing and persistent atrial fibrillation undergoing catheter ablation mimicking cox-maze procedure

Device: Endovascular ablation set mimicking cox maze 4 procedure.

Interventions

Endovascular ablation set mimicking cox maze 4 procedure. DEVICE

Endovascular pulmonary vein isolation, posterior left atrial isolation and multiple linear lesions in both atria using electroporation and radiofrequency energy.

Cohort

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent atrial fibrillation or long-standing persistent atrial fibrillation
• severely enlarged left atrium (LAVI above 50 ml/m2)

You may not qualify if:

• contraindications for electroporation
• contraindications for general anaesthesia
• age above 80 years
• less than 1 year life expectancy
• thrombus formation in left atrium
• acute life-threatening disease
• severe valvular disease requiring intervention
• previous ablation in left atrium
• secondary atrial fibrillation

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Osrednjaslovenska, 1000, Slovenia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Tine Prolic Kalinsek, MD

  UMCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: monocentric prospective nonrandomized cohort study

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 3, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 01-MAR-2026 until 01-MAR-2030
• Access Criteria: Researchers upon reasonable request.

Locations

SL (1)