Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Not Applicable

Completed

Brief Summary: The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF.

The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.

Recruitment & Eligibility

Inclusion Criteria

Male and female at least 21 years of age
persistent Afib with one prior failed ablation for persistent or long standing persistent Afib

Exclusion Criteria

Inability to sign consent
Patients with a life expectancy less than one (1) year
Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study
Pregnant women and women that are breast feeding
Patients with multiple (2 or more) prior failed ablations
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Arm && Interventions

Group	Intervention	Description
EMR Feasibility	Electrogram Morphology Mapping (EMR)	In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.

Primary Outcome Measures

Name	Time	Method
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility	2 hours	As measured by number of patients where real-time EMR mapping is completed.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events	30 days	Number of participants with treatment emergent adverse events will be measured by the type of adverse event, severity, and whether the AE/SAE is related to the mapping
Ablation Acute Effects	2 hours	ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%.