Safety and Efficacy of Left Atrial Ablation After Percutaneous Left Atrial Appendage Occlusion in High-Bleeding-Risk Patients With Atrial Fibrillation: PROCEED-AF Ablation Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 198
- Locations
- 20
- Primary Endpoint
- Patient characteristics
Study Overview
Brief Summary
The purpose of this multicenter study is to collect information from routine clinical practices for patients with left atrial appendage occlusion (LAAO) devices presenting for pulmonary vein isolation (PVI) or left atrial ablation. Assessment will include characterization of patient characteristics, procedural details, management of post-procedure anticoagulation, and clinical outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals aged >18 years
- •Undergoing any type of atrial fibrillation ablation or left atrial arrhythmia ablation
Exclusion Criteria
- •Missing essential baseline characteristics and/or missing collection of sufficient details regarding each complication
Arms & Interventions
Individuals undergoing atrial ablation for routine care
Individuals undergoing any type of atrial fibrillation ablation or left atrial arrhythmia ablation for routine care
Intervention: Data collection (Other)
Outcomes
Primary Outcomes
Patient characteristics
Time Frame: Month 0, baseline
Data will be collected to characterize patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation
Procedural characteristics
Time Frame: Month 0, during procedure
Data will be collected to characterize pulmonary vein isolation or left atrial ablation procedural details for patients with left atrial appendage occlusion devices
Post-procedure anticoagulation management
Time Frame: Through 24 months
Data will be collected to characterize post-procedure anticoagulation management for patients with left atrial appendage occlusion devices
Clinical outcomes
Time Frame: Through 24 months
Data will be collected to characterize clinical outcomes for patients with left atrial appendage occlusion devices presenting for pulmonary vein isolation or left atrial ablation
Secondary Outcomes
- Procedure-related complications(Through 6 months)