Skip to main content
OpenTrials
Completed

NCT Number: NCT02059369

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Disease Attributes Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum München

Munich, 80636, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Left atrial thrombus

Treatment and study plan

PVI+CFAE+DCC

Procedure

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

PVI, CFAE, anterior and roof line, DCC

Procedure

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

Primary outcomes

  1. Freedom from atrial arrhythmia

    Time frame: 12 months

    Documented freedom from atrial arrhythmia (AF or AT) recurrence

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Acronym: ADLINE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.