Back to resultsEsophageal Cooling for AF Ablation (eCoolAF)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophageal Cooling
Control
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients above the age of 18 years old.
- Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
- Patients must be able to understand and critically review the informed consent form.
Exclusion Criteria:
- Patients whom are unable to provide informed consent.
- Patients with contraindication to EGD.
- History of prior AF ablation procedures.
- Significant co-morbidities that preclude standard ablation procedure.
Patient is ineligible for EnsoETM placement due to:
- Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
- Known ingestion of acidic or caustic poisons within the prior 24 hours.
- Patients with <40 kg of body mass.
Sites / Locations
- University of Pennsylvania - Perelman Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Esophageal Cooling
Control
Arm Description
Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).
Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).
Outcomes
Primary Outcome Measures
Number and Percentage of Participants With Esophageal Thermal Injury
Any injury, occurrence rate measured by EGD
Number and Percentage of Participants With Esophageal Injury Based on Severity
The severity of injury measured by EGD
Secondary Outcome Measures
Posterior Wall Ablation Parameters: Temperature
Catheter Temperature
Posterior Wall Ablation Parameters
Impedance drop (absolute difference)
Occurrence of Acute PV Reconnection
Number of Participants with Acute PV Reconnection
Full Information
NCT ID
NCT03691571
First Posted
September 7, 2018
Last Updated
September 28, 2022
Sponsor
University of Pennsylvania
Collaborators
Attune Medical
1. Study Identification
Unique Protocol Identification Number
NCT03691571
Brief Title
Esophageal Cooling for AF Ablation
Acronym
eCoolAF
Official Title
Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Attune Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
Detailed Description
The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, blinded single center pilot study
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esophageal Cooling
Arm Type
Experimental
Arm Description
Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).
Intervention Type
Device
Intervention Name(s)
Esophageal Cooling
Other Intervention Name(s)
Attune Medical Esophageal Heat Transfer Device, EnsoETM
Intervention Description
The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage.
Intervention Type
Device
Intervention Name(s)
Control
Other Intervention Name(s)
Standard of care
Intervention Description
Standard of care involves standard temperature probe monitoring.
Primary Outcome Measure Information:
Title
Number and Percentage of Participants With Esophageal Thermal Injury
Description
Any injury, occurrence rate measured by EGD
Time Frame
Day 1 to 2
Title
Number and Percentage of Participants With Esophageal Injury Based on Severity
Description
The severity of injury measured by EGD
Time Frame
Day 1 to 2
Secondary Outcome Measure Information:
Title
Posterior Wall Ablation Parameters: Temperature
Description
Catheter Temperature
Time Frame
Day 0
Title
Posterior Wall Ablation Parameters
Description
Impedance drop (absolute difference)
Time Frame
Day 0
Title
Occurrence of Acute PV Reconnection
Description
Number of Participants with Acute PV Reconnection
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients above the age of 18 years old.
Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
Patients must be able to understand and critically review the informed consent form.
Exclusion Criteria:
Patients whom are unable to provide informed consent.
Patients with contraindication to EGD.
History of prior AF ablation procedures.
Significant co-morbidities that preclude standard ablation procedure.
Patient is ineligible for EnsoETM placement due to:
Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
Known ingestion of acidic or caustic poisons within the prior 24 hours.
Patients with <40 kg of body mass.
Facility Information:
Facility Name
University of Pennsylvania - Perelman Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Esophageal Cooling for AF Ablation
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