Continuous Versus Discontinuous Design of Encircling Lesions During Ablation for Atrial Fibrillation

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: catheter ablation

• Registration Number: NCT03332862
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary

Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery.

Detailed Description

The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Durable PVI is cornerstone for long-term freedom of AF. In one previous study continuous ablation was suggested to be more efficient in durable PVI. However, this hypothesis has not been proven in randomized fashion.

The current study is to confirm whether continuous versus discontinuous design of encircling lesions are comparable under the same conditions of power delivery.

The study design is a two-centre prospective randomized trial to compare the acute efficacy by using the above described approaches.

Study Timeline

• Study Start: 2017-09-15
• Status Verified: 2017-11
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-01
• Last Update Submitted: 2017-11-01
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinuous ablation	catheter ablation	perform discontinuous ablation of ipsilateral pulmunary veins.
Continuous ablation	catheter ablation	perform continuous ablation of ipsilateral pulmunary veins.

Primary Outcome Measures

Name	Time	Method
Combined unsuccessful PVI or PV reconnection	30 min after ablation	Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time

Secondary Outcome Measures

Name	Time	Method
Early pulmunary veins reconnection	10 min.	Early pulmunary veins reconnection within the first 10 min after PVI

Trial Locations

Locations (1)

Institute for Clinical and Experimental Medicine; 🇨🇿 Praha, Czechia