Benefit of CFAE Ablation

NCT ID: NCT01711047

Last Updated: 2017-10-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-08-31

Brief Summary

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The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation in addition to pulmonary vein isolation and linear ablations improves single procedural success rate over a 12 month follow up period.

Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Keywords

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catheter ablation atrial fibrillation pulmonary vein isolation linear ablation CFAE ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PVI + Linear ablation

Arm A: patients have PVI and roof and mitral isthmus lines

Group Type ACTIVE_COMPARATOR

Radiofrequency catheter Ablation

Intervention Type PROCEDURE

In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines)

PVI + linear ablation + CFAE

Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation

Group Type ACTIVE_COMPARATOR

Radiofrequency catheter ablation

Intervention Type PROCEDURE

In this arm, catheter ablation would be performed in the left atrium, including pulmonary vein isolation, linear ablations (roof and mitral isthmus lines) and Complex Fractionated Atrial Electrograms (CFAE) ablation.

Interventions

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Radiofrequency catheter Ablation

In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines)

Intervention Type PROCEDURE

Radiofrequency catheter ablation

In this arm, catheter ablation would be performed in the left atrium, including pulmonary vein isolation, linear ablations (roof and mitral isthmus lines) and Complex Fractionated Atrial Electrograms (CFAE) ablation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* persistent atrial fibrillation

Exclusion Criteria

* previous catheter or surgical ablation for atrial fibrillation
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Wong KC, Paisey JR, Sopher M, Balasubramaniam R, Jones M, Qureshi N, Hayes CR, Ginks MR, Rajappan K, Bashir Y, Betts TR. No Benefit of Complex Fractionated Atrial Electrogram Ablation in Addition to Circumferential Pulmonary Vein Ablation and Linear Ablation: Benefit of Complex Ablation Study. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1316-24. doi: 10.1161/CIRCEP.114.002504. Epub 2015 Aug 17.

Reference Type DERIVED
PMID: 26283145 (View on PubMed)

Other Identifiers

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09/H0605/97

Identifier Type: -

Identifier Source: org_study_id