- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055961
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
Intervention / Treatment
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
- Name: Colleen Balius
- Phone Number: 9497641497
- Email: colleen.balius@hoag.org
Study Locations
-
-
California
-
Newport Beach, California, United States, 92663
- Recruiting
- Hoah Memorial Hospital Presbyterian
-
Contact:
- Colleen Balius, BSN, RN
- Phone Number: 949-764-1497
- Email: colleen.balius@hoag.org
-
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:
- Adult patients
- 18 years and older
- 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
Additional Relevant MeSH Terms
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.
Clinical Trials on Atrial Fibrillation
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Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
Beijing Anzhen HospitalJohnson & Johnson; Heart Health Research CenterNot yet recruitingParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
-
Maastricht UniversityRadboud University Medical Center; Maastricht University Medical CenterRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Atrial Fibrillation ParoxysmalNetherlands
Clinical Trials on Atrial Fibrillation Ablation
-
Heart and Diabetes Center North-Rhine WestfaliaCompletedHeart Failure | Atrial FibrillationGermany
-
Centre Hospitalier Universitaire de NīmesCompleted
-
University of ChicagoUnknownAtrial FibrillationUnited States
-
Biosense Webster, Inc.CompletedParoxysmal Atrial FibrillationUnited States, Canada
-
Heart Rhythm Clinical and Research Solutions, LLCAbbottTerminatedAtrial FibrillationUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingAtrial Fibrillation RecurrentItaly
-
Central Hospital, Nancy, FranceRecruiting
-
University Hospital of FerraraCompletedAtrial FibrillationItaly
-
Barts & The London NHS TrustCompleted
-
Ottawa Heart Institute Research CorporationHeart and Stroke Foundation of CanadaRecruitingAtrial FibrillationCanada