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OpenTrials
Enrolling by Invitation

NCT Number: NCT07446244

Catheter Ablation of Advanced Forms of Atrial Fibrillation

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.

Enrolling by Invitation

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, Osrednjaslovenska, 1000, Slovenia

About this study

Patients with long-standing and persistent atrial fibrillation with severely dilated left atrium will undergo pulmonary vein isolation, box-lesion set of posterior wall, lateral mitral line (Marshall vein ablation and coronary sinus ablation per operator's discretion, anterior line, cavotricuspid line, superior caval vein isolation, intercaval line and inferior septal line. Ablations will be performed with either radiofrequency energy or pulsed field ablation at operator's discretion. Block at each line will be checked at the end of the procedure. The procedure will be performed with compliance of producer recommendation and hospital protocol.

All patients will be invited back at three months after index procedure for an invasive remap. At the remap procedure, pulmonary veins and posterior wall will be checked for isolation and all the additional lines will be checked for conduction block. Any gaps in lines will be ablated per operator's discretion.

Patients will undergo a period follow-up visit at 3, 6, and 12-month period. They will undergo a medical history taking, physical examination, ECG, and 7-day Holter ECG. Any documented atrial arrhythmia lasting more than 30 seconds after 8 week blanking period will be documented as a recurrence of atrial fibrillation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Atrial arrhythmia recurrence

    Time frame: 12 months

    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.

Secondary outcomes

  1. Efficacy of endovascular Cox maze procedure

    Time frame: 12 month

    Atrial fibrillation burden will be assessed with 7-day Holter ECG at 3, 6 and 12 months post procedure.

  2. Interventions

    Time frame: 12 months

    Initiations of antiarrhythmic drug therapy, number of cardioversions, number of repeat procedures after index procedure will be assessed.

  3. Durability of ablation lines and isolations

    Time frame: 3 months

    Number of durable blocks across ablation lines and durable isolations (pulmonary veins, superior vena cava) on invasive remap at 3 months will be assessed.

  4. Safety of catheter ablation procedure

    Time frame: 6 months

    Incidence of adverse events defined as events, which require prolonged hospitalization, additional intervention or permanent damage to patients health or cause death in a 180 day period after catheter ablation.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Acronym: ENDO MAZE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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