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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
64 pole basket catheter
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring atrial fibrillation, cardiac ablation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

64 pole basket catheter

Arm Description

all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation

Outcomes

Primary Outcome Measures

Percentage of Drivers in Right Atrial
To determine where atypical areas of drivers might be.
Time to Ablation of All Sources
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
percentage of patients
Average Number of Rotors/Focal Drivers in Diverse Locations

Secondary Outcome Measures

Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs
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
mean time to recurrence of atrial fibrillation
Single-procedure Freedom From Atrial Fibrillation
percentage of patients without prior ablation
Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation
percentage of all patients who had ablation perfornmed

Full Information

First Posted
April 6, 2012
Last Updated
March 9, 2016
Sponsor
Virginia Commonwealth University
Collaborators
University of California
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1. Study Identification

Unique Protocol Identification Number
NCT01581437
Brief Title
Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps
Acronym
CONFIRM
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
University of California

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, cardiac ablation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
64 pole basket catheter
Arm Type
Other
Arm Description
all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
64 pole basket catheter
Other Intervention Name(s)
Constellation basket catheter
Intervention Description
The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Primary Outcome Measure Information:
Title
Percentage of Drivers in Right Atrial
Description
To determine where atypical areas of drivers might be.
Time Frame
30 min
Title
Time to Ablation of All Sources
Description
total time taken to ablate all sources of rotors/focal sources in driver locations
Time Frame
30 minutes
Title
Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources
Description
percentage of patients
Time Frame
30 minutes
Title
Average Number of Rotors/Focal Drivers in Diverse Locations
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs
Description
To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers.
Time Frame
30 min
Title
Mean Time to Recurrence of Atrial Fibrillation
Description
mean time to recurrence of atrial fibrillation
Time Frame
1 year
Title
Single-procedure Freedom From Atrial Fibrillation
Description
percentage of patients without prior ablation
Time Frame
one year
Title
Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation
Description
percentage of all patients who had ablation perfornmed
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth A Ellenbogen, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23130890
Citation
Shivkumar K, Ellenbogen KA, Hummel JD, Miller JM, Steinberg JS. Acute termination of human atrial fibrillation by identification and catheter ablation of localized rotors and sources: first multicenter experience of focal impulse and rotor modulation (FIRM) ablation. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1277-85. doi: 10.1111/jce.12000. Epub 2012 Nov 6.
Results Reference
result
PubMed Identifier
23993247
Citation
Baykaner T, Clopton P, Lalani GG, Schricker AA, Krummen DE, Narayan SM; CONFIRM Investigators. Targeted ablation at stable atrial fibrillation sources improves success over conventional ablation in high-risk patients: a substudy of the CONFIRM Trial. Can J Cardiol. 2013 Oct;29(10):1218-26. doi: 10.1016/j.cjca.2013.07.672. Epub 2013 Aug 30.
Results Reference
result

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

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