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| Name | Class |
|---|---|
| Attune Medical | OTHER |
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This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults. Half of participants will receive the EnsoETM in addition to RF ablation, while the other half will receive luminal esophageal temperature (LET) monitoring during RF ablation.
Study Specific Procedures:
Standard Care Procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophageal thermal regulation device | Experimental |
| |
| LET monitoring | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnsoETM | Device | Use of esophageal thermal regulation device during radiofrequency ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal Mucosal Damage | Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme. Higher scores on this scale indicate a worse outcome. The grading system is as follows: Grade 0: Normal Examination; Grade 1: Edema and Hypermia of the Mucosa; Grade 2a: Superficial ulceration, erosions, friability, blisters, exudates, hemorrhages, whitish membranes; Grade 2b: Grade 2a pluse deep discrete or circumferential ulcerations; Grade 3a: Small scattered areas of multiple ulceration and areas of necrosis with brown-black or greyish discoloration; Grade 3b: Extensive necrosis. For this grading scale we used the following scoring: 0=0 1=1 2a=2 2b=3 3a=4 3b=5 | The post-intervention outcome measure was performed within 1 day after Pulmonary Vein Isolation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants With Treatment-Emergent Adverse Events [Safety and Adverse Events] | 3 months | |
| Presence of Esophageal Submucosal Damage, Indicated by Number of Ulcers as Assessed by Endoscopic Ultrasound (EUS) | Altered submucosal tissue architecture as assessed by endoscopic ultrasound (EUS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Medical Center | Kankakee | Illinois | 60901 | United States |
No washout or run-in occurred after participants were enrolled in the study. Of the 7 patients that were recruited, one subject was excluded from the research study, because his BMI was outside of the study inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esophageal Thermal Regulation Device | EnsoETM: Use of esophageal thermal regulation device during radiofrequency ablation. |
| FG001 | LET Monitoring | Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Esophageal Thermal Regulation Device | EnsoETM: Use of esophageal thermal regulation device during radiofrequency ablation. |
| BG001 | LET Monitoring | Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Esophageal Mucosal Damage | Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme. Higher scores on this scale indicate a worse outcome. The grading system is as follows: Grade 0: Normal Examination; Grade 1: Edema and Hypermia of the Mucosa; Grade 2a: Superficial ulceration, erosions, friability, blisters, exudates, hemorrhages, whitish membranes; Grade 2b: Grade 2a pluse deep discrete or circumferential ulcerations; Grade 3a: Small scattered areas of multiple ulceration and areas of necrosis with brown-black or greyish discoloration; Grade 3b: Extensive necrosis. For this grading scale we used the following scoring: 0=0 1=1 2a=2 2b=3 3a=4 3b=5 | Posted | Mean | Full Range | score on a scale | The post-intervention outcome measure was performed within 1 day after Pulmonary Vein Isolation. |
|
Adverse event monitoring was performed over the course of three months after the subject's surgery.
There are no differences in the definition of adverse event or serious adverse event from the clinicaltrials.gov definition.
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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 Thermal Regulation Device | EnsoETM: Use of esophageal thermal regulation device during radiofrequency ablation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brad Suprenant | Riverside Medical Center | (815) 939-9400 | blsuprenant@comcast.net |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2018 | Mar 26, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be blinded to which condition they were assigned; the Outcomes Assessor will be blinded to the hypotheses of the study as well as the condition to which the participant was assigned.
| Conventional Care | Procedure | Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure. |
|
|
| 1 day |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Baseline measure was collected via electronic chart review after informed consent was obtained and documented. | Count of Participants | Participants |
|
| OG001 | LET Monitoring | Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure. |
|
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| Secondary | Number and Percentage of Participants With Treatment-Emergent Adverse Events [Safety and Adverse Events] | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Presence of Esophageal Submucosal Damage, Indicated by Number of Ulcers as Assessed by Endoscopic Ultrasound (EUS) | Altered submucosal tissue architecture as assessed by endoscopic ultrasound (EUS) | Posted | Mean | Full Range | Ulcers | 1 day |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | LET Monitoring | Conventional Care: Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure. | 0 | 3 | 0 | 3 | 0 | 3 |
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