Esophageal Cooling for AF Ablation

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 7, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The occurrence rate of esophageal thermal injury between groups measured by EGD[ Time Frame: Day 1 to 2 ]

The severity and size of esophageal injury between groups measured by EGD[ Time Frame: Day 1 to 2 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Posterior wall ablation parameters: Temperature[ Time Frame: Day 0 ]
initial and maximum temperatures
Posterior wall ablation parameters: Impedance drop[ Time Frame: Day 0 ]
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

Descriptive Information

Brief Title ^ICMJE

Esophageal Cooling for AF Ablation

Official Title ^ICMJE

Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)

Brief Summary

The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.

Detailed Description

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. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, blinded single center pilot study
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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.
Device: Control
Standard of care involves standard temperature probe monitoring.

Study Arms

Experimental: Esophageal Cooling
Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).
Active Comparator: Control
Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2019

Estimated Primary Completion Date

September 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 able to understand and critically review the informed consent form. Exclusion Criteria: 1. Patients whom are unable to provide informed consent. 2. Patients with contraindication to EGD. 3. History of prior AF ablation procedures. 4. Significant co-morbidities that preclude standard ablation procedure. 5. 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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