Trial Outcomes & Findings for Esophageal Temperature Management During Cryo AF Ablation (EnsoETM) (NCT NCT04079634)
NCT ID: NCT04079634
Last Updated: 2023-05-16
Results Overview
Endoscopic evidence of thermal injury
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Post-Procedure Day 1
Results posted on
2023-05-16
Participant Flow
Participant milestones
| Measure |
Treatment
Placement of study device (EnsoETM) for temperature management
Esophageal warming: Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure
|
Control
Placement of standard temperature probe
Control: Standard temperature probe monitoring
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
19
|
|
Overall Study
COMPLETED
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=23 Participants
Placement of study device (EnsoETM) for temperature management
Esophageal warming: Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure
|
Control
n=19 Participants
Placement of standard temperature probe
Control: Standard temperature probe monitoring
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=23 Participants
|
7 Participants
n=19 Participants
|
19 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=23 Participants
|
12 Participants
n=19 Participants
|
23 Participants
n=42 Participants
|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 11.0 • n=23 Participants
|
66.6 years
STANDARD_DEVIATION 8.4 • n=19 Participants
|
65.6 years
STANDARD_DEVIATION 9.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=23 Participants
|
3 Participants
n=19 Participants
|
12 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=23 Participants
|
16 Participants
n=19 Participants
|
30 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
23 participants
n=23 Participants
|
19 participants
n=19 Participants
|
42 participants
n=42 Participants
|
|
Hypertension (HTN)
|
12 participants
n=23 Participants
|
13 participants
n=19 Participants
|
25 participants
n=42 Participants
|
|
Diabetes
|
2 participants
n=23 Participants
|
1 participants
n=19 Participants
|
3 participants
n=42 Participants
|
|
Coronary Artery Disease (CAD)
|
2 participants
n=23 Participants
|
1 participants
n=19 Participants
|
3 participants
n=42 Participants
|
|
Cerebrovascular Accident (CVA)
|
3 participants
n=23 Participants
|
2 participants
n=19 Participants
|
5 participants
n=42 Participants
|
|
Paroxysmal Atrial Fibrillation (AF)
|
14 participants
n=23 Participants
|
11 participants
n=19 Participants
|
25 participants
n=42 Participants
|
|
Persistent Atrial Fibrillation (AF)
|
9 participants
n=23 Participants
|
8 participants
n=19 Participants
|
17 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Post-Procedure Day 1Endoscopic evidence of thermal injury
Outcome measures
| Measure |
Treatment
n=23 Participants
Placement of study device (EnsoETM) for temperature management
Esophageal warming: Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure
|
Control
n=19 Participants
Placement of standard temperature probe
Control: Standard temperature probe monitoring
|
|---|---|---|
|
Number of Participants With Esophageal Thermal Injury
|
8 participants
|
1 participants
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place