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

NCT ID: NCT03332862

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Keywords

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Catheter Ablation Atrial Fibrillation Contact Force Continuous Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Discontinuous ablation

perform discontinuous ablation of ipsilateral pulmunary veins.

Group Type EXPERIMENTAL

catheter ablation

Intervention Type PROCEDURE

catheter ablation for atrial fibrillation treatment

Continuous ablation

perform continuous ablation of ipsilateral pulmunary veins.

Group Type ACTIVE_COMPARATOR

catheter ablation

Intervention Type PROCEDURE

catheter ablation for atrial fibrillation treatment

Interventions

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catheter ablation

catheter ablation for atrial fibrillation treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role collaborator

3rd Department of Internal Medicine - Cardiology

UNKNOWN

Sponsor Role collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bashar Aldhoon

Dr. Bashar Aldhoon, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bashar Aldhoon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical and Experimental Medicine

Locations

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Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Bashar Aldhoon, MD, PhD

Role: CONTACT

Phone: +420739528025

Email: baaĺ@ikem.cz

Facility Contacts

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Bashar Aldhoon, MD,PhD

Role: primary

References

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Aldhoon B, Peichl P, Osmancik P, Konecny P, Kautzner J, Wichterle D. Acute efficacy of contiguous versus temporally discontiguous point-by-point radiofrequency pulmonary vein isolation in patients with paroxysmal atrial fibrillation: a randomized study. J Interv Card Electrophysiol. 2022 Sep;64(3):661-667. doi: 10.1007/s10840-021-01113-9. Epub 2022 Jan 6.

Reference Type DERIVED
PMID: 34988847 (View on PubMed)

Other Identifiers

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G-17-06-22

Identifier Type: -

Identifier Source: org_study_id