NCT Number: NCT02830750
Low Fluoroscopy Afib Ablation Registry
Prospective data collection of patients undergoing Atrial Fibrillation Ablation.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Beacon Medical Group, South Bend, Indiana, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Atrial Fibrillation
Time frame: 12 months
Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data
Secondary outcomes
-
Fluoroscopic Usage
Time frame: post operative
To determine total amount of radiation used at each procedure by estimation of mGy
Sponsors and collaborators
Lead sponsor
Stanford University
Other
Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Beacon Medical Group
- Brigham and Women's Hospital
Registry information
Official study title
A Multi Center Registry of Low- Fluoroscopy Atrial Fibrillation Ablation Using Electroanatomic Mapping Carto
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jul 13, 2016
- Registry last updated
- Apr 26, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination
NCT05820295
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial DetailsEffect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling
NCT05993897
Arrhythmias, Cardiac, Atrial Fibrillation
Aswān, Aswan Governorate, Egypt
View Trial DetailsA Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation
NCT05357690
Arrhythmias, Cardiac, Atrial Fibrillation
Rochester, Minnesota, United States
View Trial DetailsThe Norwegian Exercise in Atrial Fibrillation Trial
NCT05164718
Arrhythmias, Cardiac, Atrial Fibrillation
Drammen, Norway
View Trial Details