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

Atrial Fibrillation Clinical Trial

— ADLINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059369
• Other study ID #: GER-EP-013
• Status: Completed
• Phase: N/A
• First received: May 23, 2013
• Last updated: April 10, 2017
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with symptomatic persistent AF

• After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia

Exclusion Criteria:

• Left atrial thrombus

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Procedure:
• PVI+CFAE+DCC
pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists
• PVI, CFAE, anterior and roof line, DCC
PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial arrhythmia	Documented freedom from atrial arrhythmia (AF or AT) recurrence	12 months
Secondary	Procedural and safety data	Duration of procedure, ablation time, fluoroscopy time and complications	12 months
Secondary	Number and result of reablation procedure	Number of redo procedures, results and type of recurrent arrhythmia	12 months