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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02059369
Acronym
ADLINE
Enrollment
90
Registered
2014-02-11
Start date
2012-08-31
Completion date
2014-12-31
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Recurrence

Keywords

Atrial fibrillation, Recurrence, CFAE, linear ablation

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.

Interventions

PROCEDUREPVI+CFAE+DCC

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

PROCEDUREPVI, CFAE, anterior and roof line, DCC

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

Sponsors

Deutsches Herzzentrum Muenchen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Left atrial thrombus

Design outcomes

Primary

MeasureTime frameDescription
Freedom from atrial arrhythmia12 monthsDocumented freedom from atrial arrhythmia (AF or AT) recurrence

Secondary

MeasureTime frameDescription
Procedural and safety data12 monthsDuration of procedure, ablation time, fluoroscopy time and complications
Number and result of reablation procedure12 monthsNumber of redo procedures, results and type of recurrent arrhythmia

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026