Status:
COMPLETED
Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Attune Medical
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 cryob...
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 mu...
Eligibility Criteria
Inclusion
- Patients above the age of 18 years old.
- Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
- Patients must be willing to provide informed consent.
Exclusion
- 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:
- 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.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04079634
Start Date
October 8 2019
End Date
December 31 2022
Last Update
May 16 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University
Chicago, Illinois, United States, 60611