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

March 9, 2016 updated by: Virginia Commonwealth University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • Constellation basket catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Drivers in Right Atrial
Time Frame: 30 min
To determine where atypical areas of drivers might be.
30 min
Time to Ablation of All Sources
Time Frame: 30 minutes
total time taken to ablate all sources of rotors/focal sources in driver locations
30 minutes
Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources
Time Frame: 30 minutes
percentage of patients
30 minutes
Average Number of Rotors/Focal Drivers in Diverse Locations
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 min
Mean Time to Recurrence of Atrial Fibrillation
Time Frame: 1 year
mean time to recurrence of atrial fibrillation
1 year
Single-procedure Freedom From Atrial Fibrillation
Time Frame: one year
percentage of patients without prior ablation
one year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

University of California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (ESTIMATE)

April 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM13720

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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