Low Fluoroscopy Afib Ablation Registry

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02830750
• Lead Sponsor: Stanford University

Brief Summary

Prospective data collection of patients undergoing Atrial Fibrillation 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-13
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation	12 months	Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data

Secondary Outcome Measures

Name	Time	Method
Fluoroscopic Usage	post operative	To determine total amount of radiation used at each procedure by estimation of mGy

Trial Locations

Locations (2)

Beacon Medical Group; 🇺🇸 South Bend, Indiana, United States

Brigham's Women's Hospital; 🇺🇸 Boston, Massachusetts, United States