N/A N=10 Treatment

Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT03082963 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Aug 2023

Primary outcome: Primary: Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility — 10 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Electrogram Morphology Mapping (EMR) (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Jeffrey Goldberger
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility	10	—
SECONDARY Ablation Acute Effects	3	—
SECONDARY Number of Participants With Treatment Emergent Adverse Events	2	—
SECONDARY Ablation Acute Effects	3	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03082963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.