Trial Outcomes & Findings for Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures (NCT NCT04063761)
NCT ID: NCT04063761
Last Updated: 2025-06-17
Results Overview
Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours. Measured as total procedure time as documented by clinician recorder and research coordinator.
COMPLETED
NA
20 participants
Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours
2025-06-17
Participant Flow
Participant milestones
| Measure |
Esophageal Cooling
Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device
esophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
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 Cooling
n=20 Participants
Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device
esophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study
|
|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 11 • n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hoursStudy Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours. Measured as total procedure time as documented by clinician recorder and research coordinator.
Outcome measures
| Measure |
Esophageal Cooling
n=20 Participants
Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device
esophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study
|
|---|---|
|
Total Time of Active Ablation Procedure
|
3.26 Hours
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours after procedure. Measured as total procedure time to discharge to PACU as documented by clinician recorder and research coordinator.
Outcome measures
| Measure |
Esophageal Cooling
n=20 Participants
Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device
esophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study
|
|---|---|
|
Total Procedure Time
|
5.11 Hours
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hoursNumber of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
Outcome measures
| Measure |
Esophageal Cooling
n=20 Participants
Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device
esophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study
|
|---|---|
|
Number of Procedural Pauses During Left Atrial Instrumentation
|
0 Procedural pauses
Interval 0.0 to 0.168
|
Adverse Events
Esophageal Cooling
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