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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01581437
First received: April 6, 2012
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Atrial Fibrillation
 Procedure: 64 pole basket catheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Recording for Potential AF Drivers and Patient Specific Atrial Anatomy and Atrial Electrogram Maps Using an FDA Approved 64-Pole Basket Catheter (CONFIRM)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Atypical areas of drivers [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
    To determine where atypical areas of drivers might be.


Secondary Outcome Measures:
  • 64 pole basket catheter [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
    To determin if the 64 pole basket catheter will be successfully used by non-UCSD EP Labs to gather information on AF drivers.


Estimated Enrollment: 15
Study Start Date: October 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 64 pole basket catheter
    The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
    Other Name: Constellation basket catheter
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581437

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Kenneth A Ellenbogen, MD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01581437     History of Changes
Other Study ID Numbers: HM13720
Study First Received: April 6, 2012
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
atrial fibrillation
cardiac ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013