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

NCT ID: NCT01581437

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-12-31

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

64 pole basket catheter

Intervention Type: PROCEDURE

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

Interventions

64 pole basket catheter

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

Intervention Type: PROCEDURE

Other Intervention Names

Constellation basket catheter

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth A Ellenbogen, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23130890 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23993247 (View on PubMed)

Other Identifiers

HM13720

Identifier Type: -

Identifier Source: org_study_id