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

This study has been completed.
Sponsor:
Collaborator:
University of California
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01581437
First received: April 6, 2012
Last updated: March 9, 2016
Last verified: March 2016
  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:


Further study details as provided by Virginia Commonwealth University:

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

  • Time to Ablation of All Sources [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    total time taken to ablate all sources of rotors/focal sources in driver locations

  • Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    percentage of patients

  • Average Number of Rotors/Focal Drivers in Diverse Locations [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
    To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers.

  • Mean Time to Recurrence of Atrial Fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    mean time to recurrence of atrial fibrillation

  • Single-procedure Freedom From Atrial Fibrillation [ Time Frame: one year ] [ Designated as safety issue: No ]
    percentage of patients without prior ablation

  • Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    percentage of all patients who had ablation perfornmed


Enrollment: 78
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
64 pole basket catheter
all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California
Investigators
Principal Investigator: Kenneth A Ellenbogen, MD Virginia Commonwealth University
  More Information

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01581437     History of Changes
Other Study ID Numbers: HM13720 
Study First Received: April 6, 2012
Results First Received: June 5, 2015
Last Updated: March 9, 2016
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 September 27, 2016