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OpenTrials
Completed

NCT Number: NCT02830750

Low Fluoroscopy Afib Ablation Registry

Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beacon Medical Group, South Bend, Indiana, United States

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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

Ablation

Procedure

Primary outcomes

  1. Atrial Fibrillation

    Time frame: 12 months

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

Secondary outcomes

  1. 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.

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