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Low Fluoroscopy Afib Ablation Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830750
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
Beacon Medical Group
Brigham and Women's Hospital
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Information provided by (Responsible Party):
Gerri O'Riordan, Stanford University

Brief Summary:
Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: Ablation

Detailed Description:
Clinicians who have experience using low dose fluoroscopy including use of Carto Mapping system will consent patients to allow data collection and a 12 month f/up visit to track adverse events. Clinicians will follow a protocol which will be similar to their standard of care for ablations.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 160 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Multi Center Registry of Low- Fluoroscopy Atrial Fibrillation Ablation Using Electroanatomic Mapping Carto
Study Start Date : April 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Atrial Fibrillation [ Time Frame: 12 months ]
    Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data


Secondary Outcome Measures :
  1. Fluoroscopic Usage [ Time Frame: post operative ]
    To determine total amount of radiation used at each procedure by estimation of mGy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have persistant or paroxysmal atrial fibrillation
Criteria

Inclusion Criteria:

  • Patient meets accepted AHA/ACC/HRS guideline indications for catheter ablation of paroxysmal or persistent AF
  • First or subsequent ablation procedures may be included
  • Age 18-75

Exclusion Criteria:

  • Known venous malformations or implanted instrumentation (IVC filter)
  • Known PV stenosis
  • Unable to provide consent
  • H/O mechanical mitral valve replacement (unable to rely on EA mapping only)
  • Documented left atrial thrombus
  • Prior ASD repair Pregnancy
  • NYHA >=3
  • EF less than 35%
  • CHF within 90 daysRecent MI or coronary revascularization within 90 days
  • NOTE: H/O implanted pacemaker or ICD with transvenous leads will NOT be an exclusion criteria, but we will track patients treated with pre-existing transvenous leads with the hypothesis that although fluoroscopy use will be higher in these patients compared to those without leads, but still lower than conventionally treated patients.
  • Patients who are undergoing non- standard of care ablations ie, Cyro or FIRM ablations

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): NCT02830750


Locations
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United States, Indiana
Beacon Medical Group
South Bend, Indiana, United States, 46601
United States, Massachusetts
Brigham's Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Stanford University
Beacon Medical Group
Brigham and Women's Hospital
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Investigators
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Principal Investigator: Chad Brodt, MD PHD Stanford University

Additional Information:

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Responsible Party: Gerri O'Riordan, Direcetor of Clinical Resarch. CV Med, Stanford University
ClinicalTrials.gov Identifier: NCT02830750    
Other Study ID Numbers: 35821
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes