Atrial Fibrillation Ablation Registry (AFib)

February 27, 2023 updated by: Colleen Balius, Hoag Memorial Hospital Presbyterian

Atrial Fibrillation Ablation Registry Protocol Number: 3122-2016

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoah Memorial Hospital Presbyterian
        • Contact:
        • Principal Investigator:
          • Colleen Balius, BSN, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients, 18 years and older, undergoing percutaneous catheter ablation procedures to treat atrial fibrillation

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unsuccessful treatment rate
Time Frame: 1 year
measured by the number of repeated procedure
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Leila Andres, Hoag Memorial Hospital Presbyterian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Anticipated)

May 20, 2025

Study Completion (Anticipated)

May 20, 2025

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 171-19-CV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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