Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2022-06-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EMR Feasibility

In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.

Group Type OTHER

Electrogram Morphology Mapping (EMR)

Intervention Type DEVICE

Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium \& then the left atrium.

Interventions

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Electrogram Morphology Mapping (EMR)

Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium \& then the left atrium.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No