Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Study Overview
=================
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.

Official Title
-----------------
Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Electrogram Morphology Mapping (EMR)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EMR Feasibility<br>In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. | Device: Electrogram Morphology Mapping (EMR)<br>* Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium & then the left atrium.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility | As measured by number of patients where real-time EMR mapping is completed. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation Acute Effects | ablation based on EMR map as measured by number of participants that terminate atrial fibrillation. | 2 hours | 
| Number of Participants With Treatment Emergent Adverse Events | 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 | 30 days | 
| Ablation Acute Effects | ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%. | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, ablation