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Atrial Fibrillation Ablation Registry (AFib)

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ClinicalTrials.gov Identifier: NCT04055961
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Colleen Balius, 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).

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Atrial Fibrillation Ablation

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Atrial Fibrillation Ablation Registry Protocol Number: 3122-2016
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : May 20, 2025
Estimated Study Completion Date : May 20, 2025

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Unsuccessful treatment rate [ Time Frame: 1 year ]
    measured by the number of repeated procedure


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients, 18 years and older, undergoing percutaneous catheter ablation procedures to treat atrial fibrillation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055961


Locations
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United States, California
Hoah Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Colleen Balius, BSN, RN    949-764-1497    colleen.balius@hoag.org   
Principal Investigator: Colleen Balius, BSN, RN         
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian

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Responsible Party: Colleen Balius, Clinical Data Coordinator, Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT04055961     History of Changes
Other Study ID Numbers: 171-19-CV
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes