Esophageal Cooling for AF Ablation (eCoolAF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03691571|
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Esophageal Cooling Device: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, blinded single center pilot study|
|Official Title:||Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)|
|Actual Study Start Date :||October 11, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Esophageal Cooling
Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).
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.
Active Comparator: Control
Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).
Standard of care involves standard temperature probe monitoring.
Other Name: Standard of care
- Esophageal thermal injury between groups measured by EGD [ Time Frame: Day 1 to 2 ]Any injury, occurrence rate measured by EGD
- Esophageal injury between groups [ Time Frame: Day 1 to 2 ]The severity and size of injury measured by EGD
- Posterior wall ablation parameters: Temperature [ Time Frame: Day 0 ]initial and maximum temperatures
- Posterior wall ablation parameters [ Time Frame: Day 0 ]Impedance drop (absolute difference)
- Occurrence of acute PV reconnection [ Time Frame: Day 0 ]PV reconnection present or no as recorded in Carto
- Location of acute PV reconnection [ Time Frame: Day 0 ]Location of PV reconnection present or no as recorded in Carto
- Freedom from AF [ Time Frame: 3 months, 6 months, and 12 months ]Clinically documented Atrial Fibrillation via review of multiple data sources in clinical record
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691571
|Contact: Pasquale Santangeli, MD,PhDfirstname.lastname@example.org|
|Contact: Cory Tschabrunn, PhD, CEPSemail@example.com|
|United States, Pennsylvania|
|University of Pennsylvania - Perelman Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Tiffany Sharkoski, MPH, MBE 215-615-2354 firstname.lastname@example.org|
|Principal Investigator: Pasquale Santangeli, MD, PhD|
|Principal Investigator: Cory M Tschabrunn, PhD, CEPS|