Atrial Fibrillation
Conditions
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.
Interventions
DEVICEEsophageal 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.
DEVICEControl
Standard of care involves standard temperature probe monitoring.
Sponsors
Attune Medical
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Randomized, blinded single center pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With Esophageal Thermal Injury | Day 1 to 2 | Any injury, occurrence rate measured by EGD |
| Number and Percentage of Participants With Esophageal Injury Based on Severity | Day 1 to 2 | The severity of injury measured by EGD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posterior Wall Ablation Parameters: Temperature | Day 0 | Catheter Temperature |
| Posterior Wall Ablation Parameters | Day 0 | Impedance drop (absolute difference) |
| Occurrence of Acute PV Reconnection | Day 0 | Number of Participants with Acute PV Reconnection |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Control Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).
Control: Standard of care involves standard temperature probe monitoring. | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 9 | 2 |
Baseline characteristics
| Characteristic | Total | Control | Esophageal Cooling |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 9.4 | 63.6 years STANDARD_DEVIATION 9.3 | 62.8 years STANDARD_DEVIATION 9.6 |
| BMI | 30.8 kg/m^2 STANDARD_DEVIATION 6.3 | 31.0 kg/m^2 STANDARD_DEVIATION 5.1 | 30.5 kg/m^2 STANDARD_DEVIATION 7.3 |
| CAD, n (%) | 5 Participants | 4 Participants | 1 Participants |
| CHA2DS2-VASc Score | 2.2 risk stratification score 1-9 STANDARD_DEVIATION 1.5 | 2.2 risk stratification score 1-9 STANDARD_DEVIATION 1.6 | 2.2 risk stratification score 1-9 STANDARD_DEVIATION 1.4 |
| Diabetes, n (%) | 3 Participants | 2 Participants | 1 Participants |
| Hypertension, n (%) | 25 Participants | 13 Participants | 12 Participants |
| LVEF (%) | 55.2 percentage STANDARD_DEVIATION 10.4 | 55.8 percentage STANDARD_DEVIATION 9.4 | 54.7 percentage STANDARD_DEVIATION 11.4 |
| Paroxysmal AF, n (%) | 25 Participants | 14 Participants | 11 Participants |
| Prior stroke/TIA n (%) | 5 Participants | 2 Participants | 3 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 30 Participants | 16 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 10 / 22 | 9 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Number and Percentage of Participants With Esophageal Injury Based on Severity
The severity of injury measured by EGD
Time frame: Day 1 to 2
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Esophageal Cooling | Number and Percentage of Participants With Esophageal Injury Based on Severity | Grade 1 - Mild | 1 Participants |
| Esophageal Cooling | Number and Percentage of Participants With Esophageal Injury Based on Severity | Grade 2 - Moderate | 6 Participants |
| Esophageal Cooling | Number and Percentage of Participants With Esophageal Injury Based on Severity | Grade 3 - Severe | 1 Participants |
| Control | Number and Percentage of Participants With Esophageal Injury Based on Severity | Grade 1 - Mild | 2 Participants |
| Control | Number and Percentage of Participants With Esophageal Injury Based on Severity | Grade 2 - Moderate | 0 Participants |
| Control | Number and Percentage of Participants With Esophageal Injury Based on Severity | Grade 3 - Severe | 3 Participants |
Primary
Number and Percentage of Participants With Esophageal Thermal Injury
Any injury, occurrence rate measured by EGD
Time frame: Day 1 to 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Esophageal Cooling | Number and Percentage of Participants With Esophageal Thermal Injury | 8 Participants |
| Control | Number and Percentage of Participants With Esophageal Thermal Injury | 5 Participants |
| Total | Number and Percentage of Participants With Esophageal Thermal Injury | 13 Participants |
Comparison: Esophageal thermal injury was detected in 13/44 (30%) patients.p-value: >0.05Fisher Exact
Secondary
Occurrence of Acute PV Reconnection
Number of Participants with Acute PV Reconnection
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Esophageal Cooling | Occurrence of Acute PV Reconnection | 6 Participants |
| Control | Occurrence of Acute PV Reconnection | 1 Participants |
p-value: 0.1Fisher Exact
Secondary
Posterior Wall Ablation Parameters
Impedance drop (absolute difference)
Time frame: Day 0
Population: Maximum tissue impedance drop during radiofrequency ablation application as recorded by the electroanatomic mapping system.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esophageal Cooling | Posterior Wall Ablation Parameters | 10 ohms | Standard Deviation 2 |
| Control | Posterior Wall Ablation Parameters | 10 ohms | Standard Deviation 2 |
p-value: 0.73Wilcoxon (Mann-Whitney)
Secondary
Posterior Wall Ablation Parameters: Temperature
Catheter Temperature
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esophageal Cooling | Posterior Wall Ablation Parameters: Temperature | 25.0 celcius | Standard Deviation 1.5 |
| Control | Posterior Wall Ablation Parameters: Temperature | 25.7 celcius | Standard Deviation 1.5 |
p-value: 0.11Wilcoxon (Mann-Whitney)