Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Electrogram Morphology Mapping (EMR)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EMR Feasibility; In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation.	Device: 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.

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

Collaborators and Investigators

• Sponsor: Jeffrey Goldberger
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Raul Mitrani, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): June 18, 2022
• Study Completion (Actual): June 18, 2022

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 12, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 20150757; 1R41HL127907-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes