eCoolAF: Esophageal Cooling for AF Ablation

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT03691571
• Collaborator: Attune Medical (Other)
• Enrollment: 55
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.6
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Esophageal Cooling; Device: Control	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, blinded single center pilot studyRandomized, blinded single center pilot study
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)
• Actual Study Start Date: Oct 11, 2018
• Actual Primary Completion Date: Mar 25, 2020
• Actual Study Completion Date: Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esophageal Cooling Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).	Device: Esophageal Cooling; 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.; Other Names: Attune Medical Esophageal Heat Transfer Device EnsoETM
Active Comparator: Control Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).	Device: Control; Standard of care involves standard temperature probe monitoring.; Other Names: Standard of care

Outcome Measures

Primary Outcome Measures

1. Number and Percentage of Participants With Esophageal Thermal Injury [Day 1 to 2]

   Any injury, occurrence rate measured by EGD

2. Number and Percentage of Participants With Esophageal Injury Based on Severity [Day 1 to 2]

   The severity of injury measured by EGD

Secondary Outcome Measures

1. Posterior Wall Ablation Parameters: Temperature [Day 0]

   Catheter Temperature

2. Posterior Wall Ablation Parameters [Day 0]

   Impedance drop (absolute difference)

3. Occurrence of Acute PV Reconnection [Day 0]

   Number of Participants with Acute PV Reconnection

4. Location of Acute PV Reconnection [Day 0]

   Location of PV reconnection present or no as recorded in Carto

5. Freedom From AF [3 months, 6 months, and 12 months]

   Clinically documented Atrial Fibrillation via review of multiple data sources in clinical record

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients above the age of 18 years old.

2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.

3. Patients must be able to understand and critically review the informed consent form.

Exclusion Criteria:

1. Patients whom are unable to provide informed consent.

2. Patients with contraindication to EGD.

3. History of prior AF ablation procedures.

4. Significant co-morbidities that preclude standard ablation procedure.

5. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania - Perelman Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• Attune Medical

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 16, 2019
• Informed Consent Form - Mar 4, 2020

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03691571
• Other Study ID Numbers: 831401
• First Posted: Oct 1, 2018
• Last Update Posted: Dec 21, 2021
• Last Verified: Nov 1, 2021

• 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
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details

This prospective, randomized, single-center study included patients with symptomatic atrial fibrillation (AF) undergoing first-time radiofrequency catheter ablation between October 2018 and March 2020 at the Hospital of Pennsylvania. Patients were randomized in a 1:1 fashion to achieve esophageal cooling with no luminal esophageal temperature (LET) monitoring (device group) or standard LET monitoring (control group).

Pre-assignment Detail

Of 55 enrolled patients, 11 patients withdrew from the study prior to completing the post-procedure endocervical glandular dysplasia (EGD) due to delays obtaining the EGD prior to discharge.

Arm/Group Title	Esophageal Cooling	Control
Arm/Group Description	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Esophageal Cooling: 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.	Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
Period Title: Overall Study
STARTED	31	24
COMPLETED	22	22
NOT COMPLETED	9	2

Baseline Characteristics

Arm/Group Title	Esophageal Cooling	Control	Total
Arm/Group Description	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Esophageal Cooling: 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.	Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.	Total of all reporting groups
Overall Participants	22	22	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.8 (9.6)	63.6 (9.3)	63.2 (9.4)
Sex: Female, Male (Count of Participants)
Female	8 36.4%	6 27.3%	14 31.8%
Male	14 63.6%	16 72.7%	30 68.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.5 (7.3)	31.0 (5.1)	30.8 (6.3)
Paroxysmal AF, n (%) (Count of Participants)
Count of Participants [Participants]	11 50%	14 63.6%	25 56.8%
LVEF (%) (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	54.7 (11.4)	55.8 (9.4)	55.2 (10.4)
CHA2DS2-VASc Score (risk stratification score 1-9) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [risk stratification score 1-9]	2.2 (1.4)	2.2 (1.6)	2.2 (1.5)
Hypertension, n (%) (Count of Participants)
Count of Participants [Participants]	12 54.5%	13 59.1%	25 56.8%
CAD, n (%) (Count of Participants)
Count of Participants [Participants]	1 4.5%	4 18.2%	5 11.4%
Diabetes, n (%) (Count of Participants)
Count of Participants [Participants]	1 4.5%	2 9.1%	3 6.8%
Prior stroke/TIA n (%) (Count of Participants)
Count of Participants [Participants]	3 13.6%	2 9.1%	5 11.4%

Outcome Measures

1. Primary Outcome

Title	Number and Percentage of Participants With Esophageal Thermal Injury
Description	Any injury, occurrence rate measured by EGD
Time Frame	Day 1 to 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esophageal Cooling	Control	Total
Arm/Group Description	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Esophageal Cooling: 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.	Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.	Total number of participants with esophageal thermal injury
Measure Participants	22	22	44
Count of Participants [Participants]	8 36.4%	5 22.7%	13 29.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total
	Comments	Esophageal thermal injury was detected in 13/44 (30%) patients.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>.05
	Comments
	Method	Fisher Exact
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esophageal Cooling	Control
Arm/Group Description	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Esophageal Cooling: 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.	Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
Measure Participants	8	5
Grade 1 - Mild	1 4.5%	2 9.1%
Grade 2 - Moderate	6 27.3%	0 0%
Grade 3 - Severe	1 4.5%	3 13.6%

3. Secondary Outcome

Title	Posterior Wall Ablation Parameters: Temperature
Description	Catheter Temperature
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esophageal Cooling	Control
Arm/Group Description	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Esophageal Cooling: 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.	Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
Measure Participants	22	22
Mean (Standard Deviation) [celcius]	25.0 (1.5)	25.7 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Esophageal Cooling, Control
	Comments
	Type of Statistical Test	Other
	Comments	feasibility/pilot study
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Posterior Wall Ablation Parameters
Description	Impedance drop (absolute difference)
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Maximum tissue impedance drop during radiofrequency ablation application as recorded by the electroanatomic mapping system.

Arm/Group Title	Esophageal Cooling	Control
Arm/Group Description	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Esophageal Cooling: 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.	Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
Measure Participants	22	22
Mean (Standard Deviation) [ohms]	10 (2)	10 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Esophageal Cooling, Control
	Comments
	Type of Statistical Test	Other
	Comments	feasibility/pilot study
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Occurrence of Acute PV Reconnection
Description	Number of Participants with Acute PV Reconnection
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esophageal Cooling	Control
Arm/Group Description	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Esophageal Cooling: 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.	Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
Measure Participants	22	22
Count of Participants [Participants]	6 27.3%	1 4.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Esophageal Cooling, Control
	Comments
	Type of Statistical Test	Other
	Comments	feasibility/pilot study
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	Location of Acute PV Reconnection
Description	Location of PV reconnection present or no as recorded in Carto
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Freedom From AF
Description	Clinically documented Atrial Fibrillation via review of multiple data sources in clinical record
Time Frame	3 months, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Approximately 1 month post EGD.
Arm/Group Title	Esophageal Cooling		Control
Arm/Group Description	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Esophageal Cooling: 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.		Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
All Cause Mortality
	Esophageal Cooling		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)
Serious Adverse Events
	Esophageal Cooling		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Esophageal Cooling		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/22 (45.5%)		9/22 (40.9%)
Nervous system disorders
Maximum Core Body Temperature Decrease	3/22 (13.6%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Sore Throat or Cough	10/22 (45.5%)		9/22 (40.9%)
Mild Cough with Trace Blood-Tinged Sputum	1/22 (4.5%)		0/22 (0%)

Limitations/Caveats

Pilot study with a relatively small patient pool; Provides an initial assessment regarding the potential clinical benefit of active esophageal cooling for prevention of thermal injury; Fixed ablation parameters and limited to a single ablation catheter technology; Unclear if findings will be reproducible with different ablation strategies or with different ablation technologies. Larger, multi-center studies are needed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.