Clinical trial NCT01581437: Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps
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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
cardiac ablation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of California
First posted: 2012-04-20
Enrollment: 78
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Percentage of Drivers in Right Atrial
timeFrame: 30 min
measure: Time to Ablation of All Sources
timeFrame: 30 minutes
measure: Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources
timeFrame: 30 minutes
measure: Average Number of Rotors/Focal Drivers in Diverse Locations
timeFrame: 30 minutes
Secondary outcomes:
measure: Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs
timeFrame: 30 min
measure: Mean Time to Recurrence of Atrial Fibrillation
timeFrame: 1 year
measure: Single-procedure Freedom From Atrial Fibrillation
timeFrame: one year
measure: Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation
timeFrame: 1 year
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kenneth A Ellenbogen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.