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

NCT01581437 | Completed Results DMC

• 1 other identifier: HM13720
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; cardiac ablation

Outcome Measures

Primary Outcomes (4)

• Percentage of Drivers in Right Atrial

  To determine where atypical areas of drivers might be.

  30 min

• Time to Ablation of All Sources

  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

  percentage of patients

  30 minutes

• Average Number of Rotors/Focal Drivers in Diverse Locations

  30 minutes

Secondary Outcomes (4)

• Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs

  30 min

• Mean Time to Recurrence of Atrial Fibrillation

  1 year

• Single-procedure Freedom From Atrial Fibrillation

  one year

• Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation

  1 year

Study Arms (1)

64 pole basket catheter

OTHER

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

Interventions

64 pole basket catheter PROCEDURE

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

Also known as: Constellation basket catheter

64 pole basket catheter

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of California: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• 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.

  PMID: 23130890 RESULT

• 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.

  PMID: 23993247 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kenneth Ellenbogen
• Organization: Virginia CU

kellenbogen@mcvh-vcu.edu

804-828-7565

Study Officials

• Kenneth A Ellenbogen, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 20, 2012
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 11, 2016
• Results First Posted: March 11, 2016

Record last verified: 2016-03

Locations

US (1)