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

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ClinicalTrials.gov Identifier: NCT02059369
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Recurrence Procedure: PVI+CFAE+DCC Procedure: PVI, CFAE, anterior and roof line, DCC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

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Arm Intervention/treatment
Active Comparator: CFAE ablation
Intervention: Complex fractionated atrial electrograms (CFAE) Ablation
Procedure: PVI+CFAE+DCC
pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists

Active Comparator: CFAE + Lines
CFAE Ablation followed by linear lesions (anterior and Roof line)
Procedure: PVI, CFAE, anterior and roof line, DCC
PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists




Primary Outcome Measures :
  1. Freedom from atrial arrhythmia [ Time Frame: 12 months ]
    Documented freedom from atrial arrhythmia (AF or AT) recurrence


Secondary Outcome Measures :
  1. Procedural and safety data [ Time Frame: 12 months ]
    Duration of procedure, ablation time, fluoroscopy time and complications

  2. Number and result of reablation procedure [ Time Frame: 12 months ]
    Number of redo procedures, results and type of recurrent arrhythmia



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Left atrial thrombus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059369


Locations
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Germany
Deutsches Herzzentrum München
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen

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Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT02059369     History of Changes
Other Study ID Numbers: GER-EP-013
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Deutsches Herzzentrum Muenchen:
Atrial fibrillation
Recurrence
CFAE
linear ablation

Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes