Atrial Fibrillation
Conditions
Brief summary
Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. Delivery of radiofrequency (RF) energy necessary to perform left atrial ablation has the potential to cause injury to the nearby esophagus including ulceration, hematoma, spasm, esophageal motility disorders, and, in the most extreme case, atrial-esophageal fistula (AEF). Esophageal mucosal lesions are the likely precursor to AEF, and esophageal mucosal lesions have been detected on post-ablation endoscopy after pulmonary vein isolation with an incidence ranging from 3% to 60%. Active esophageal cooling during RF ablation as a means of esophageal injury prevention has been investigated through mathematical models, pre-clinical studies, and in clinical trials. Existing data support the efficacy of this approach, but the practice has not been widely adopted due to lack of a commercially available device. The aim or purpose of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to cool the esophagus during left atrial RF ablation.
Detailed description
This study is a prospective, pilot study using the Attune Medical esophageal heat transfer device to actively cool the esophagus during RF ablation procedures. This design is appropriate to gather the data needed regarding overall procedural time, compare this to historical controls, and estimate a sample size for a larger study powered for statistical significance. The subjects will undergo preparation and anesthesia procedures following standard practice. Once the patient is intubated, the esophageal heat transfer device will be placed into the esophagus according to the Instructions for Use (IFU). The device will remain in place until the ablation procedure is completed and will be removed before extubation. Posterior left atrial wall ablation using standard parameters will only be performed when the esophageal heat transfer device has reached a temperature of 4-6 degrees C for at least 2 minutes. The device will be set to neutral or warming temperature (37-42 degrees C) during other aspects of the procedure (such as mapping and anterior wall ablations). All patients will be followed up in total for 6 weeks (Long Term Follow-up visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.
Interventions
Prospective, single center pilot study
Sponsors
University of Iowa
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (age over 18 years) * Undergoing first left atrial ablation for the treatment of atrial fibrillation (AF) including pulmonary vein isolation * Undergoing catheter-based ablation procedure using radiofrequency energy * Patients must be able to understand and critically review the informed consent form. * Subjects must understand and agree to study requirements and sign a written informed consent.
Exclusion criteria
* Patients who are unable to provide informed consent. * History of prior atrial fibrillation (AF) ablation procedures. * Significant co-morbidities that preclude standard ablation procedure. * Patients with \<40 kg of body mass * Patients with relevant esophageal pathology (e.g. esophageal cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Time of Active Ablation Procedure | Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours | Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours. Measured as total procedure time as documented by clinician recorder and research coordinator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Procedure Time | Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU) | Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours after procedure. Measured as total procedure time to discharge to PACU as documented by clinician recorder and research coordinator. |
| Number of Procedural Pauses During Left Atrial Instrumentation | Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours | Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Esophageal Cooling Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device
esophageal cooling device (Attune Medical, Chicago, IL): Prospective, single center pilot study | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Esophageal Cooling | — |
|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 11 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Total Time of Active Ablation Procedure
Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours. Measured as total procedure time as documented by clinician recorder and research coordinator.
Time frame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esophageal Cooling | Total Time of Active Ablation Procedure | 3.26 Hours | Standard Deviation 0.7 |
Secondary
Number of Procedural Pauses During Left Atrial Instrumentation
Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
Time frame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Esophageal Cooling | Number of Procedural Pauses During Left Atrial Instrumentation | 0 Procedural pauses |
Secondary
Total Procedure Time
Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours after procedure. Measured as total procedure time to discharge to PACU as documented by clinician recorder and research coordinator.
Time frame: Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esophageal Cooling | Total Procedure Time | 5.11 Hours | Standard Deviation 0.59 |