Low Fluoroscopy Afib Ablation Registry

A Multi Center Registry of Low- Fluoroscopy Atrial Fibrillation Ablation Using Electroanatomic Mapping Carto

Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• United States
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Beacon Medical Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham's Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have persistant or paroxysmal atrial fibrillation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation	Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluoroscopic Usage	To determine total amount of radiation used at each procedure by estimation of mGy	post operative

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Brigham and Women's Hospital; Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); Beacon Medical Group
• Investigators: Principal Investigator: Chad Brodt, MD PHD, Stanford University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 35821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO