Skip to content

Low Fluoroscopy Afib Ablation Registry

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02830750
Enrollment
160
Registered
2016-07-13
Start date
2016-04-30
Completion date
2018-04-30
Last updated
2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

PROCEDUREAblation

Sponsors

Beacon Medical Group
CollaboratorUNKNOWN
Brigham and Women's Hospital
CollaboratorOTHER
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Atrial Fibrillation12 monthsDetermine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data

Secondary

MeasureTime frameDescription
Fluoroscopic Usagepost operativeTo determine total amount of radiation used at each procedure by estimation of mGy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026