Trial Outcomes & Findings for Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA (NCT NCT02467166)

Last Updated: 2021-06-02

Results Overview

The number of esophageal lesions observed by esophageal endoscopy after left atrial radiofrequency catheter ablation for atrial fibrillation.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Day 1

Results posted on

2021-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Circa™ Probe The Circa™ Probe will be used during the RFCA to monitor esophageal temperature. Following ablation, the esophagoscopy will be performed to examine the esophagus for resulting thermal lesions. Circa™ Probe: The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation esophagoscopy will be performed to assess for esophageal lesions.
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Circa™ Probe n=36 Participants The Circa™ Probe will be used during the RFCA to monitor esophageal temperature. Following ablation, the esophagoscopy will be performed to examine the esophagus for resulting thermal lesions. Circa™ Probe: The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation esophagoscopy will be performed to assess for esophageal lesions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age, Continuous	64.2 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	5 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	36 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
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Among the 36 patients in this study, 18 underwent esophagoscopy immediately after ablation for atrial fibrillation and 18 underwent esophagoscopy 1 day after ablation. The pre-specified intent of this analysis was to determine the number of esophageal lesions, if any, in the entire group of 36 patients, with analysis done immediately or one day after ablation, so as to not miss any lesions which may have taken up to 24 hours to appear.

The number of esophageal lesions observed by esophageal endoscopy after left atrial radiofrequency catheter ablation for atrial fibrillation.

Outcome measures

Outcome measures
Measure	Circa™ Probe n=36 Participants Circa™ Probe: The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation, esophagoscopy will be performed to assess for any esophageal lesions. The first phase of the study consisted of patients who were to undergo esophagoscopy immediately after ablation and the second phase of the study in patients 24 hours after ablation.
Number of Esophageal Lesions.	1 esophageal lesions

Adverse Events

Circa™ Probe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gregory K. Feld, MD, Director CCEP

University of California, San Diego Health System

Phone: (858) 246-2972

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place