Trial Outcomes & Findings for Esophageal Cooling for AF Ablation (NCT NCT03691571)

NCT ID: NCT03691571

Last Updated: 2022-10-05

Results Overview

Any injury, occurrence rate measured by EGD

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: Day 1 to 2
• Results posted on: 2022-10-05

Participant Flow

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).

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.

Participant milestones

Measure	Esophageal Cooling 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.	Control Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
Overall Study STARTED	31	24
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	9	2

Reasons for withdrawal

Measure	Esophageal Cooling 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.	Control Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
Overall Study Withdrawal by Subject	9	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Esophageal Cooling n=22 Participants 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.	Control n=22 Participants Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.	Total n=44 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 9.6 • n=22 Participants	63.6 years STANDARD_DEVIATION 9.3 • n=22 Participants	63.2 years STANDARD_DEVIATION 9.4 • n=44 Participants
Sex: Female, Male Female	8 Participants n=22 Participants	6 Participants n=22 Participants	14 Participants n=44 Participants
Sex: Female, Male Male	14 Participants n=22 Participants	16 Participants n=22 Participants	30 Participants n=44 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	30.5 kg/m^2 STANDARD_DEVIATION 7.3 • n=22 Participants	31.0 kg/m^2 STANDARD_DEVIATION 5.1 • n=22 Participants	30.8 kg/m^2 STANDARD_DEVIATION 6.3 • n=44 Participants
Paroxysmal AF, n (%)	11 Participants n=22 Participants	14 Participants n=22 Participants	25 Participants n=44 Participants
LVEF (%)	54.7 percentage STANDARD_DEVIATION 11.4 • n=22 Participants	55.8 percentage STANDARD_DEVIATION 9.4 • n=22 Participants	55.2 percentage STANDARD_DEVIATION 10.4 • n=44 Participants
CHA2DS2-VASc Score	2.2 risk stratification score 1-9 STANDARD_DEVIATION 1.4 • n=22 Participants	2.2 risk stratification score 1-9 STANDARD_DEVIATION 1.6 • n=22 Participants	2.2 risk stratification score 1-9 STANDARD_DEVIATION 1.5 • n=44 Participants
Hypertension, n (%)	12 Participants n=22 Participants	13 Participants n=22 Participants	25 Participants n=44 Participants
CAD, n (%)	1 Participants n=22 Participants	4 Participants n=22 Participants	5 Participants n=44 Participants
Diabetes, n (%)	1 Participants n=22 Participants	2 Participants n=22 Participants	3 Participants n=44 Participants
Prior stroke/TIA n (%)	3 Participants n=22 Participants	2 Participants n=22 Participants	5 Participants n=44 Participants

PRIMARY outcome

Timeframe: Day 1 to 2

Any injury, occurrence rate measured by EGD

Outcome measures

Measure	Esophageal Cooling n=22 Participants 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.	Control n=22 Participants Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.	Total n=44 Participants Total number of participants with esophageal thermal injury
Number and Percentage of Participants With Esophageal Thermal Injury	8 Participants	5 Participants	13 Participants

PRIMARY outcome

Timeframe: Day 1 to 2

The severity of injury measured by EGD

Outcome measures

Measure	Esophageal Cooling n=8 Participants 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.	Control n=5 Participants Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.	Total Total number of participants with esophageal thermal injury
Number and Percentage of Participants With Esophageal Injury Based on Severity Grade 1 - Mild	1 Participants	2 Participants	—
Number and Percentage of Participants With Esophageal Injury Based on Severity Grade 2 - Moderate	6 Participants	0 Participants	—
Number and Percentage of Participants With Esophageal Injury Based on Severity Grade 3 - Severe	1 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Day 0

Catheter Temperature

Outcome measures

Measure	Esophageal Cooling n=22 Participants 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.	Control n=22 Participants Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.	Total Total number of participants with esophageal thermal injury
Posterior Wall Ablation Parameters: Temperature	25.0 celcius Standard Deviation 1.5	25.7 celcius Standard Deviation 1.5	—

SECONDARY outcome

Timeframe: Day 0

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

Impedance drop (absolute difference)

Outcome measures

Measure	Esophageal Cooling n=22 Participants 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.	Control n=22 Participants Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.	Total Total number of participants with esophageal thermal injury
Posterior Wall Ablation Parameters	10 ohms Standard Deviation 2	10 ohms Standard Deviation 2	—

SECONDARY outcome

Timeframe: Day 0

Number of Participants with Acute PV Reconnection

Outcome measures

Measure	Esophageal Cooling n=22 Participants 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.	Control n=22 Participants Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.	Total Total number of participants with esophageal thermal injury
Occurrence of Acute PV Reconnection	6 Participants	1 Participants	—

Adverse Events

Esophageal Cooling

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Esophageal Cooling n=22 participants at risk 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.	Control n=22 participants at risk Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring.
Respiratory, thoracic and mediastinal disorders Sore Throat or Cough	45.5% 10/22 • Approximately 1 month post EGD.	40.9% 9/22 • Approximately 1 month post EGD.
Respiratory, thoracic and mediastinal disorders Mild Cough with Trace Blood-Tinged Sputum	4.5% 1/22 • Approximately 1 month post EGD.	0.00% 0/22 • Approximately 1 month post EGD.
Nervous system disorders Maximum Core Body Temperature Decrease	13.6% 3/22 • Approximately 1 month post EGD.	0.00% 0/22 • Approximately 1 month post EGD.

Additional Information

Dr. Cory M. Tschabrunn

The Hospital of the University of Pennsylvania

Phone: 215-614-0482

Email: coryt@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place