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Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps

Not Applicable
Completed
Conditions
Atrial Fibrillation
Interventions
Procedure: 64 pole basket catheter
Registration Number
NCT01581437
Lead Sponsor
Virginia Commonwealth University
Brief Summary

The 64 pole basket catheter used for the mapping procedure will be defined "atypical" sites which sustain atrial fibrillation. The ablation through the driver will lead to more rapid ablation of the atrial fibrillation.

Detailed Description

Atrial fibrillation (AF) is a common abnormal and rapid heart rhythm characterized by erratic electrical activity of the upper chambers of the heart. This cardiac arrhythmia may lead to stroke, heart failure, low blood pressure, chest pain, and increased mortality rate. Treatment may include medication to stop the rhythm abnormality, blood thinners, and/or ablation. Ablation involves application of heat or freezing to the area sustaining the rhythm abnormality. This requires tubes (catheters)to be placed in the heart. Human atrial fibrillation may be sustained by localized drivers (rapid and/or organized sites of atrial electrical activation). By mapping/recording the patient's specific atrial anatomy and atrial electrical activity with the 64-pole basket catheter, we may add to the knowledge base of these driver locations. We may also add to the knowledge about where best to ablate to terminate the arrhythmia. Typical anatomic

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
78
Inclusion Criteria
  • Patients at VCU Medical Center who are 21 years or older undergoing EPS for ablation of persistent AF (non-rheumatic) whose AF episodes last equal to or greater than 7 days but terminate with DC cardioversion or anti-arrhythmic drugs and do not recur within 24 hours.
  • Per current standard of care, AF patients must have failed equal to or greater than 1 anti-arrhythmic drug to qualify for ablation.
Exclusion Criteria
  • Active coronary ischemic in the past year
  • Rheumatic valve disease, that leads to distinct AF and increases thromboembolic risk
  • Prior ablation or cardiac surgery, that alters atrial electophysiology
  • Left atrial clot or dense contrast on TEE, which would increase thromboembolic risk
  • Out of range serum electrolytes, including K outside 4.0-5.0 mmol/1
  • Left atrial diameter greater than 60 mm, to exclude extreme structural remodeling and failure to maintain sinus rhythm
  • Thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk
  • Pregnancy
  • Inability or unwillingness to provide informed consent
  • Unable to converse in English
  • Use of anti-arrhythmic drug less than 5 X half-life Prior ablation or cardiac surgery, that alters atrial electophysiology

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
64 pole basket catheter64 pole basket catheterall patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
Primary Outcome Measures
NameTimeMethod
Percentage of Drivers in Right Atrial30 min

To determine where atypical areas of drivers might be.

Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources30 minutes

percentage of patients

Time to Ablation of All Sources30 minutes

total time taken to ablate all sources of rotors/focal sources in driver locations

Average Number of Rotors/Focal Drivers in Diverse Locations30 minutes
Secondary Outcome Measures
NameTimeMethod
Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs30 min

To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers.

Single-procedure Freedom From Atrial Fibrillationone year

percentage of patients without prior ablation

Mean Time to Recurrence of Atrial Fibrillation1 year

mean time to recurrence of atrial fibrillation

Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation1 year

percentage of all patients who had ablation perfornmed

Trial Locations

Locations (1)

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

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