Trial Outcomes & Findings for Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation (NCT NCT03082963)

NCT ID: NCT03082963

Last Updated: 2023-08-03

Results Overview

As measured by number of patients where real-time EMR mapping is completed.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2023-08-03

Participant Flow

Participant milestones

Measure	EMR Feasibility In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation

Baseline characteristics by cohort

Measure	EMR Feasibility n=10 Participants In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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.
Age, Continuous	63.4 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

As measured by number of patients where real-time EMR mapping is completed.

Outcome measures

Measure	EMR Feasibility n=10 Participants In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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.
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility	10 Participants

SECONDARY outcome

Timeframe: 2 hours

ablation based on EMR map as measured by number of participants that terminate atrial fibrillation.

Outcome measures

Measure	EMR Feasibility n=10 Participants In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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.
Ablation Acute Effects	0 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	EMR Feasibility n=10 Participants In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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.
Number of Participants With Treatment Emergent Adverse Events	2 Participants

SECONDARY outcome

Timeframe: 2 hours

ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%.

Outcome measures

Measure	EMR Feasibility n=10 Participants In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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.
Ablation Acute Effects	3 Participants

Adverse Events

EMR Feasibility

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	EMR Feasibility n=10 participants at risk In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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.
Respiratory, thoracic and mediastinal disorders Post ablation procedure -Pulmonary edema	10.0% 1/10 • Number of events 1 • 1 year

Other adverse events

Measure	EMR Feasibility n=10 participants at risk In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. 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.
Injury, poisoning and procedural complications Pain from blood pressure cuff	10.0% 1/10 • Number of events 1 • 1 year
Cardiac disorders Exacerbation of congestive heart failure	10.0% 1/10 • Number of events 1 • 1 year

Additional Information

Dr Jeffrey Goldberger

University of Miami

Phone: 305-243-4356

Email: j-goldberger@miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place