Atrial Fibrillation Ablation Registry

Atrial Fibrillation Clinical Trial

— AFib  

Official title:

Atrial Fibrillation Ablation Registry Protocol Number: 3122-2016

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055961
• Other study ID #: 171-19-CV
• Status: Recruiting
• Start date: May 20, 2019
• Est. completion date: May 20, 2025

Study information

• Verified date: February 2023
• Source: Hoag Memorial Hospital Presbyterian
• Contact: Colleen Balius
• Phone: 9497641497
• Email: colleen.balius[@]hoag.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 20, 2025
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients

2. 18 years and older

3. Undergoing percutaneous catheter ablation procedures to treat atrial fibrillation

Exclusion Criteria:

1. none

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Atrial Fibrillation Ablation
A procedure used to treat an irregular heart rhythm (arrhythmia)

Locations

Country	Name	City	State
United States	Hoah Memorial Hospital Presbyterian	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unsuccessful treatment rate	measured by the number of repeated procedure	1 year
Secondary	Adverse Events	Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)	1 year