Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082963
• Other study ID #: 20150757
• Secondary ID: 1R41HL127907-01A
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: June 18, 2022

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 18, 2022
• Est. primary completion date: June 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Jeffrey Goldberger	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility	As measured by number of patients where real-time EMR mapping is completed.	2 hours
Secondary	Ablation Acute Effects	ablation based on EMR map as measured by number of participants that terminate atrial fibrillation.	2 hours
Secondary	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
Secondary	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