Clinical Trials Logo

Clinical Trial 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.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 of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to warm the esophagus during left atrial cryoablation.


Clinical Trial Description

This study is a prospective, pilot study using the Attune Medical ensoETM esophageal heat transfer device to actively warm the esophagus during cryoablation 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. Once patient consent is obtained, the subject 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 IFU. The device will remain in place until the ablation procedure is completed and will be removed before extubation. Left atrial cryoablation using the standard approach will be performed with the ensoETM set at a temperature of 42 degrees C. All patients will be followed up in total for 6 weeks (Long Term FU visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04087122
Study type Interventional
Source Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Contact
Status Completed
Phase N/A
Start date September 30, 2019
Completion date December 31, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04115735 - His Bundle Recording From Subclavian Vein
Recruiting NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A
Completed NCT03313167 - Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
Active, not recruiting NCT04544397 - Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
Completed NCT02923414 - Comparison of High Versus Escalating Shocks in Cardioverting Atrial Fibrillation N/A
Recruiting NCT04850508 - Validation of the Advisor HD Grid Mapping Catheter in Atrial Fibrillation Ablation
Recruiting NCT04590898 - Peri-device Leakage Closure After LAAO
Completed NCT03593486 - Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation N/A
Active, not recruiting NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Recruiting NCT05080712 - Progression of Atrial Fibrillation in the Young
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Terminated NCT04076917 - Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
Active, not recruiting NCT03259373 - IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation N/A
Not yet recruiting NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Recruiting NCT04037397 - First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3) Phase 3