Trial Outcomes & Findings for Esophageal Cooling in Radiofrequency Cardiac Ablation (NCT NCT03481023)
NCT ID: NCT03481023
Last Updated: 2024-02-28
Results Overview
Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme. Higher scores on this scale indicate a worse outcome. The grading system is as follows: Grade 0: Normal Examination; Grade 1: Edema and Hypermia of the Mucosa; Grade 2a: Superficial ulceration, erosions, friability, blisters, exudates, hemorrhages, whitish membranes; Grade 2b: Grade 2a pluse deep discrete or circumferential ulcerations; Grade 3a: Small scattered areas of multiple ulceration and areas of necrosis with brown-black or greyish discoloration; Grade 3b: Extensive necrosis. For this grading scale we used the following scoring: 0=0 1=1 2a=2 2b=3 3a=4 3b=5
COMPLETED
NA
6 participants
The post-intervention outcome measure was performed within 1 day after Pulmonary Vein Isolation.
2024-02-28
Participant Flow
No washout or run-in occurred after participants were enrolled in the study. Of the 7 patients that were recruited, one subject was excluded from the research study, because his BMI was outside of the study inclusion/exclusion criteria.
Participant milestones
| Measure |
Esophageal Thermal Regulation Device
EnsoETM: Use of esophageal thermal regulation device during radiofrequency ablation.
|
LET Monitoring
Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
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 |
Esophageal Thermal Regulation Device
n=3 Participants
EnsoETM: Use of esophageal thermal regulation device during radiofrequency ablation.
|
LET Monitoring
n=3 Participants
Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Age, Continuous
|
64.7 years
n=3 Participants
|
61.3 years
n=3 Participants
|
63 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: The post-intervention outcome measure was performed within 1 day after Pulmonary Vein Isolation.Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme. Higher scores on this scale indicate a worse outcome. The grading system is as follows: Grade 0: Normal Examination; Grade 1: Edema and Hypermia of the Mucosa; Grade 2a: Superficial ulceration, erosions, friability, blisters, exudates, hemorrhages, whitish membranes; Grade 2b: Grade 2a pluse deep discrete or circumferential ulcerations; Grade 3a: Small scattered areas of multiple ulceration and areas of necrosis with brown-black or greyish discoloration; Grade 3b: Extensive necrosis. For this grading scale we used the following scoring: 0=0 1=1 2a=2 2b=3 3a=4 3b=5
Outcome measures
| Measure |
Esophageal Thermal Regulation Device
n=3 Participants
EnsoETM: Use of esophageal thermal regulation device during radiofrequency ablation.
|
LET Monitoring
n=3 Participants
Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
|
|---|---|---|
|
Esophageal Mucosal Damage
|
1 score on a scale
Interval 0.0 to 2.0
|
1.33333 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Esophageal Thermal Regulation Device
n=3 Participants
EnsoETM: Use of esophageal thermal regulation device during radiofrequency ablation.
|
LET Monitoring
n=3 Participants
Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
|
|---|---|---|
|
Number and Percentage of Participants With Treatment-Emergent Adverse Events [Safety and Adverse Events]
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 dayAltered submucosal tissue architecture as assessed by endoscopic ultrasound (EUS)
Outcome measures
| Measure |
Esophageal Thermal Regulation Device
n=3 Participants
EnsoETM: Use of esophageal thermal regulation device during radiofrequency ablation.
|
LET Monitoring
n=3 Participants
Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
|
|---|---|---|
|
Presence of Esophageal Submucosal Damage, Indicated by Number of Ulcers as Assessed by Endoscopic Ultrasound (EUS)
|
.33 Ulcers
Interval 0.0 to 1.0
|
1 Ulcers
Interval 0.0 to 2.0
|
Adverse Events
Esophageal Thermal Regulation Device
LET Monitoring
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