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

Atrial Fibrillation Clinical Trial

— CDAF  

Official title:

Acute Efficacy of Point-by-point Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation: a Randomized Comparison of Continuous Versus Discontinuous Design of Encircling Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03332862
• Other study ID #: G-17-06-22
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 1, 2017
• Start date: September 15, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: November 2017
• Source: Institute for Clinical and Experimental Medicine
• Contact: Bashar Aldhoon, MD, PhD
• Phone: +420739528025
• Email: baal[@]ikem.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• catheter ablation
catheter ablation for atrial fibrillation treatment

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Praha

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	3rd Department of Internal Medicine - Cardiology, Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined unsuccessful PVI or PV reconnection	Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time	30 min after ablation
Secondary	Early pulmunary veins reconnection	Early pulmunary veins reconnection within the first 10 min after PVI	10 min.