Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation

NCT ID: NCT02059369

Last Updated: 2017-04-11

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.

Detailed Description

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Conditions

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Atrial Fibrillation Recurrence

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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CFAE ablation

Intervention: Complex fractionated atrial electrograms (CFAE) Ablation

Group Type ACTIVE_COMPARATOR

PVI+CFAE+DCC

Intervention Type PROCEDURE

pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists

CFAE + Lines

CFAE Ablation followed by linear lesions (anterior and Roof line)

Group Type ACTIVE_COMPARATOR

PVI, CFAE, anterior and roof line, DCC

Intervention Type PROCEDURE

PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists

Interventions

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PVI+CFAE+DCC

pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists

Intervention Type PROCEDURE

PVI, CFAE, anterior and roof line, DCC

PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic persistent AF
* After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia

Exclusion Criteria

* Left atrial thrombus
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Deutsches Herzzentrum München

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GER-EP-013

Identifier Type: -

Identifier Source: org_study_id

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