Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Jeffrey Goldberger

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: Electrogram Morphology Mapping (EMR)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03082963

1R41HL127907-01A1 (U.S. NIH Grant/Contract)

20150757

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.