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

Atrial Fibrillation Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581437
• Other study ID #: HM13720
• Status: Completed
• Phase: N/A
• First received: April 6, 2012
• Last updated: March 9, 2016
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• 64 pole basket catheter
The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	University of California

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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 (FIR — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Drivers in Right Atrial	To determine where atypical areas of drivers might be.	30 min	Yes
Primary	Time to Ablation of All Sources	total time taken to ablate all sources of rotors/focal sources in driver locations	30 minutes	No
Primary	Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources	percentage of patients	30 minutes	No
Primary	Average Number of Rotors/Focal Drivers in Diverse Locations		30 minutes	No
Secondary	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.	30 min	Yes
Secondary	Mean Time to Recurrence of Atrial Fibrillation	mean time to recurrence of atrial fibrillation	1 year	No
Secondary	Single-procedure Freedom From Atrial Fibrillation	percentage of patients without prior ablation	one year	No
Secondary	Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation	percentage of all patients who had ablation perfornmed	1 year	No