Comparison of Operator-guided and Automatic Algorithm-guided Atrial Fibrillation Ablation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02476227
• Date of registration: 05/06/2015
• Prospective Registration: No
• Primary sponsor: Military Institute of Medicine, Poland
• Public title: Comparison of Operator-guided and Automatic Algorithm-guided Atrial Fibrillation Ablation
• Scientific title: Comparison of Operator-guided and Automatic Algorithm-guided Atrial Fibrillation Ablation. Randomized Open-labeled Study
• Date of first enrolment: April 2015
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02476227
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Marek Kiliszek, MD, PhD
• Affiliation: Military Institute of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with symptomatic atrial fibrillation qualified to catheter ablation according
to current standards

Exclusion Criteria:

- lack of informed consent

- two previous pulmonary vein isolations



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Procedure: Ablation using CARTO system

Primary Outcome(s)

AF recurrence [Time Frame: 1-year follow-up after index procedure]

Secondary Outcome(s)

Arrhythmia-free survival [Time Frame: Time to arrhythmia recurrence, follow-up 3-18 months after index procedure]

Secondary ID(s)

1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors