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CompletedNCT02830750Updated Apr 26, 2018

Low Fluoroscopy Afib Ablation Registry

An observational study in Atrial Fibrillation, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-26.

Sponsored by Stanford University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 160 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have persistant or paroxysmal atrial fibrillation

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
160 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • ProcedureAblation
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What researchers measure

Primary outcomes

  1. Atrial Fibrillation

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

    Time frame: 12 months

Secondary outcomes

  1. Fluoroscopic Usage

    To determine total amount of radiation used at each procedure by estimation of mGy

    Time frame: post operative

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Study locations

2 sites
  • Beacon Medical Group
    South Bend, Indiana 46601, United States
  • Brigham's Women's Hospital
    Boston, Massachusetts 02115, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02830750
Lead sponsor
Stanford University
Collaborators
Beacon Medical Group, Brigham and Women's Hospital, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Responsible party
Gerri O'Riordan (Direcetor of Clinical Resarch. CV Med, Stanford University) — Principal investigator
First posted
Jul 13, 2016
Start date
Apr 2016
Primary completion
Apr 2018
Completion
Apr 2018
Last update
Apr 26, 2018

Study contacts

Chad Brodt, MD PHD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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