Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation (ADLINE)
Primary Purpose
Atrial Fibrillation, Recurrence
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PVI+CFAE+DCC
PVI, CFAE, anterior and roof line, DCC
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Recurrence, CFAE, linear ablation
Eligibility Criteria
Inclusion Criteria:
- Patients with symptomatic persistent AF
- After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia
Exclusion Criteria:
- Left atrial thrombus
Sites / Locations
- Deutsches Herzzentrum München
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CFAE ablation
CFAE + Lines
Arm Description
Intervention: Complex fractionated atrial electrograms (CFAE) Ablation
CFAE Ablation followed by linear lesions (anterior and Roof line)
Outcomes
Primary Outcome Measures
Freedom from atrial arrhythmia
Documented freedom from atrial arrhythmia (AF or AT) recurrence
Secondary Outcome Measures
Procedural and safety data
Duration of procedure, ablation time, fluoroscopy time and complications
Number and result of reablation procedure
Number of redo procedures, results and type of recurrent arrhythmia
Full Information
NCT ID
NCT02059369
First Posted
May 23, 2013
Last Updated
April 10, 2017
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT02059369
Brief Title
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
Acronym
ADLINE
Official Title
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Recurrence
Keywords
Atrial fibrillation, Recurrence, CFAE, linear ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CFAE ablation
Arm Type
Active Comparator
Arm Description
Intervention: Complex fractionated atrial electrograms (CFAE) Ablation
Arm Title
CFAE + Lines
Arm Type
Active Comparator
Arm Description
CFAE Ablation followed by linear lesions (anterior and Roof line)
Intervention Type
Procedure
Intervention Name(s)
PVI+CFAE+DCC
Intervention Description
pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists
Intervention Type
Procedure
Intervention Name(s)
PVI, CFAE, anterior and roof line, DCC
Intervention Description
PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists
Primary Outcome Measure Information:
Title
Freedom from atrial arrhythmia
Description
Documented freedom from atrial arrhythmia (AF or AT) recurrence
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Procedural and safety data
Description
Duration of procedure, ablation time, fluoroscopy time and complications
Time Frame
12 months
Title
Number and result of reablation procedure
Description
Number of redo procedures, results and type of recurrent arrhythmia
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with symptomatic persistent AF
After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia
Exclusion Criteria:
Left atrial thrombus
Facility Information:
Facility Name
Deutsches Herzzentrum München
City
Munich
ZIP/Postal Code
80636
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
We'll reach out to this number within 24 hrs