CatHeter Ablation of perSistEnd Atrial Fibrillation: Pulmonary Vein Isolation Versus Defragmentation. The CHASE-AF Study
CHASE-AF
1 other identifier
interventional
150
1 country
1
Brief Summary
Study design: Randomized prospective comparison of pulmonary vein isolation alone versus a strategy aiming for atrial fibrillation termination by using a stepwise approach consisting of pulmonary vein isolation, biatrial defragmentation aiming for fractionated electrograms and linear ablation if required.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Nov 2010
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMay 1, 2019
April 1, 2019
3.3 years
April 16, 2012
April 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of atrial arrhythmia during 12 months follow up
12 months
Secondary Outcomes (1)
Number of periprocedural complications
12 months
Study Arms (2)
PVI alone
ACTIVE COMPARATORPulmonary vein isolation alone in persistent atrial fibrillation
PVI + Defragmentation + linear lesions
ACTIVE COMPARATORAF ablation continuation aiming for AF termination
Interventions
PVI alone Pulmonary vein isolation alone in persistent atrial fibrillation
PVI + Defragmentation + linear lesions AF ablation continuation aiming for AF termination
Eligibility Criteria
You may qualify if:
- Age \> 18
- Persistent atrial fibrillation \> 7 days or previous cardioversion
- Obtained written consent
You may not qualify if:
- Age less than 18 years
- Previous operative or interventional treatment of atrial fibrillation
- Paroxysmal atrial fibrillation
- Pregnancy
- Contraindication for oral anticoagulation
- Contraindication for heparin administration
- Transient factors causing atrial fibrillation (e.g. Hyperthyroidism)
- Drug and alcohol abuse
- Severe underlying heart disease with left atrial enlargement \> 60 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsklinikum Hamburg-Eppendorflead
- Abbott Medical Devicescollaborator
Study Sites (1)
University Hospital Eppendorf
Hamburg, 20251, Germany
Related Publications (1)
Vogler J, Willems S, Sultan A, Schreiber D, Luker J, Servatius H, Schaffer B, Moser J, Hoffmann BA, Steven D. Pulmonary Vein Isolation Versus Defragmentation: The CHASE-AF Clinical Trial. J Am Coll Cardiol. 2015 Dec 22;66(24):2743-2752. doi: 10.1016/j.jacc.2015.09.088.
PMID: 26700836DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Willems, MD
University Heart Center Hamburg
- PRINCIPAL INVESTIGATOR
Daniel Steven, MD
University Heart Center Hamburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2012
First Posted
April 18, 2012
Study Start
November 1, 2010
Primary Completion
February 1, 2014
Study Completion
February 1, 2015
Last Updated
May 1, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share