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Completed

NCT Number: NCT01581437

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

64 pole basket catheter

Procedure

The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.

Other names: Constellation basket catheter

Primary outcomes

  1. Percentage of Drivers in Right Atrial

    Time frame: 30 min

    To determine where atypical areas of drivers might be.

  2. Time to Ablation of All Sources

    Time frame: 30 minutes

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

  3. Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources

    Time frame: 30 minutes

    percentage of patients

  4. Average Number of Rotors/Focal Drivers in Diverse Locations

    Time frame: 30 minutes

Secondary outcomes

  1. Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs

    Time frame: 30 min

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

  2. Mean Time to Recurrence of Atrial Fibrillation

    Time frame: 1 year

    mean time to recurrence of atrial fibrillation

  3. Single-procedure Freedom From Atrial Fibrillation

    Time frame: one year

    percentage of patients without prior ablation

  4. Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation

    Time frame: 1 year

    percentage of all patients who had ablation perfornmed

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • University of California

Registry information

Official study title

Recording for Potential AF Drivers and Patient Specific Atrial Anatomy and Atrial Electrogram Maps Using an FDA Approved 64-Pole Basket Catheter (CONFIRM)

Acronym: CONFIRM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 20, 2012
Registry last updated
Mar 11, 2016

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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