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Clinical Trials/NCT03332862
NCT03332862UnknownNot Applicable

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

Institute for Clinical and Experimental Medicine1 site in 1 country30 target enrollmentStarted: September 15, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Combined unsuccessful PVI or PV reconnection

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Discontinuous ablation

Experimental

perform discontinuous ablation of ipsilateral pulmunary veins.

Intervention: catheter ablation (Procedure)

Continuous ablation

Active Comparator

perform continuous ablation of ipsilateral pulmunary veins.

Intervention: catheter ablation (Procedure)

Outcomes

Primary Outcomes

Combined unsuccessful PVI or PV reconnection

Time Frame: 30 min after ablation

Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time

Secondary Outcomes

  • Early pulmunary veins reconnection(10 min.)

Investigators

Sponsor
Institute for Clinical and Experimental Medicine
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Bashar Aldhoon

Dr. Bashar Aldhoon, PhD

Institute for Clinical and Experimental Medicine

Study Sites (1)

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