Atrial Fibrillation Ablation Registry

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT04055961
• Lead Sponsor: Hoag Memorial Hospital Presbyterian

Brief Summary

The Atrial Fibrillation Ablation Registry (AFib Ablation Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (AF).

Detailed Description

The Atrial Fibrillation Ablation Registry (AFib Ablation Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (AF). Patient-level data will be submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR™). The primary aims of the AFib Ablation Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous catheter ablation procedures, investigate novel quality improvement methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR data. The secondary purpose of the AFib Ablation Registry is to serve as a rich source of clinical data to support assessments of short- and long-term safety, comparative and cost effectiveness research, and as a scalable data infrastructure for post market studies.

Study Timeline

• Study Start: 2019-05-20
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2025-05-20
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. Adult patients
2. 18 years and older
3. Undergoing percutaneous catheter ablation procedures to treat atrial fibrillation

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Exclusion Criteria

1. none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Unsuccessful treatment rate	1 year	measured by the number of repeated procedure

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 year	Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)

Trial Locations

Locations (1)

Hoah Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States