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| Name | Class |
|---|---|
| Attune Medical | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophageal Cooling | Experimental | Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). |
|
| Control | Active Comparator | Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal Cooling | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants With Esophageal Thermal Injury | Any injury, occurrence rate measured by EGD | Day 1 to 2 |
| Number and Percentage of Participants With Esophageal Injury Based on Severity | The severity of injury measured by EGD | Day 1 to 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Posterior Wall Ablation Parameters: Temperature | Catheter Temperature | Day 0 |
| Posterior Wall Ablation Parameters | Impedance drop (absolute difference) |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania - Perelman Center | Philadelphia | Pennsylvania | 19104 | United States |
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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Fifty-five patients were enrolled in the study with 31 patients randomized to the device group and 24 patients randomized to the control group. Eleven patients withdrew from the study prior to completing the post-procedure EGD due to delays obtaining the EGD prior to discharge and 44 patients completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Percentage of Participants With Esophageal Thermal Injury | Any injury, occurrence rate measured by EGD | Posted | Count of Participants | Participants | Day 1 to 2 |
|
Approximately 1 month post EGD.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore Throat or Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cory M. Tschabrunn | The Hospital of the University of Pennsylvania | 215-614-0482 | coryt@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2019 | Aug 19, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2020 | Oct 8, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Randomized, blinded single center pilot study
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| Control | Device | Standard of care involves standard temperature probe monitoring. |
|
|
| Day 0 |
| Occurrence of Acute PV Reconnection | Number of Participants with Acute PV Reconnection | Day 0 |
| BG001 |
| Control |
Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Paroxysmal AF, n (%) | Count of Participants | Participants |
|
| LVEF (%) | Mean | Standard Deviation | percentage |
|
| CHA2DS2-VASc Score | Congestive heart failure, hypertension, age ≥75 years, diabetes, stroke, vascular disease, age 65-74, sex class (CHA2DS2-VASc). Calculates stroke risk for patients with atrial fibrillation. Score of 0 is "low" risk of stroke, 1 is "moderate", and any score above 1 is a "high" risk. The CHA2DS2-VASc system, with having three more potential variables, inevitably classifies more patients into a high-risk group. | Mean | Standard Deviation | risk stratification score 1-9 |
|
| Hypertension, n (%) | Count of Participants | Participants |
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| CAD, n (%) | Count of Participants | Participants |
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| Diabetes, n (%) | Count of Participants | Participants |
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| Prior stroke/TIA n (%) | Count of Participants | Participants |
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| OG002 | Total | Total number of participants with esophageal thermal injury |
|
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| Primary | Number and Percentage of Participants With Esophageal Injury Based on Severity | The severity of injury measured by EGD | Posted | Count of Participants | Participants | Day 1 to 2 |
|
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| Secondary | Posterior Wall Ablation Parameters: Temperature | Catheter Temperature | Posted | Mean | Standard Deviation | celcius | Day 0 |
|
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| Secondary | Posterior Wall Ablation Parameters | Impedance drop (absolute difference) | Maximum tissue impedance drop during radiofrequency ablation application as recorded by the electroanatomic mapping system. | Posted | Mean | Standard Deviation | ohms | Day 0 |
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| Secondary | Occurrence of Acute PV Reconnection | Number of Participants with Acute PV Reconnection | Posted | Count of Participants | Participants | Day 0 |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 10 |
| 22 |
| EG001 | Control | Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Control: Standard of care involves standard temperature probe monitoring. | 0 | 22 | 0 | 22 | 9 | 22 |
| Mild Cough with Trace Blood-Tinged Sputum | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Maximum Core Body Temperature Decrease | Nervous system disorders | Systematic Assessment | The baseline core body temperature in the device group was 36.2±0.8°C and 35.7±1.6°C during active esophageal cooling. The maximum core body temperature decrease observed during active esophageal cool was 0.5±1.2°C. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Grade 3 - Severe |
|