Atrial Fibrillation
Conditions
Brief summary
The purpose of this pilot study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the frequency or severity of thermal injury during cryoballoon ablation of atrial fibrillation.
Detailed description
Catheter ablation of atrial fibrillation (AF) has become a common ablation procedure performed worldwide. The cornerstone of this procedure is pulmonary vein isolation (PVI). PVI can be achieved by multiple methods, the two most common being radiofrequency (RF) and cryoablation. Energy delivery may extend beyond the atrial myocardium and result in damage to adjacent structures, including the esophagus. Atrio-esophageal fistula (AEF) is a rare, but a well-recognized complication of percutaneous AF ablation. The occurrence rate of esophageal injury has varied depending on the reporting center, timing of endoscopy, and the ablation technique utilized. Esophageal ulceration is likely the initial injury that leads to AEF formation and is probably present within hours to days of the ablation procedure. The Attune Medical Esophageal Heat Transfer Device (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. For this study, the EnsoETM tube will be used during cardiac ablation procedures for the intended indication of patient temperature management using approved settings/parameters as detailed in the product instructions for use document. EnsoETM is an FDA approved device. This prospective, randomized study will include 40 patients with symptomatic AF undergoing index PVI under general anesthesia at Northwestern Memorial Hospital. Patients will be randomized in a 1:1 fashion with 20 patients (Group A) randomized to undergo the ablation procedure with esophageal warming and the other 20 patients (Group B) will serve as the control group and will not have the EnsoETM device used. All patients will undergo esophagogastroduodenoscopy (EGD) 1-2 days following the ablation procedure to evaluate for esophageal injury.
Interventions
DEVICEEsophageal warming
Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure
DEVICEControl
Standard temperature probe monitoring
Sponsors
Attune Medical
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participant will not be informed if they were randomized to control or treatment until Month 2 follow-up visit.
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 willing to provide informed consent.
Exclusion criteria
1. Patients with contraindication to EGD. 2. History of prior AF ablation procedures. 3. Significant co-morbidities that preclude standard ablation procedure. 4. 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 of Participants With Esophageal Thermal Injury | Post-Procedure Day 1 | Endoscopic evidence of thermal injury |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Placement of study device (EnsoETM) for temperature management
Esophageal warming: Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure | 23 |
| Control Placement of standard temperature probe
Control: Standard temperature probe monitoring | 19 |
| Total | 42 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 12 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 7 Participants | 19 Participants |
| Age, Continuous | 64.7 years STANDARD_DEVIATION 11 | 66.6 years STANDARD_DEVIATION 8.4 | 65.6 years STANDARD_DEVIATION 9.8 |
| Cerebrovascular Accident (CVA) | 3 participants | 2 participants | 5 participants |
| Coronary Artery Disease (CAD) | 2 participants | 1 participants | 3 participants |
| Diabetes | 2 participants | 1 participants | 3 participants |
| Hypertension (HTN) | 12 participants | 13 participants | 25 participants |
| Paroxysmal Atrial Fibrillation (AF) | 14 participants | 11 participants | 25 participants |
| Persistent Atrial Fibrillation (AF) | 9 participants | 8 participants | 17 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 23 participants | 19 participants | 42 participants |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 19 |
| other Total, other adverse events | 0 / 23 | 0 / 19 |
| serious Total, serious adverse events | 0 / 23 | 0 / 19 |
Outcome results
Primary
Number of Participants With Esophageal Thermal Injury
Endoscopic evidence of thermal injury
Time frame: Post-Procedure Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Number of Participants With Esophageal Thermal Injury | 8 participants |
| Control | Number of Participants With Esophageal Thermal Injury | 1 participants |
p-value: 0.02t-test, 2 sided