Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures

NCT04087122 | Completed Results FDA Device

• 1 other identifier: WMC-Cryo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Total Time of Active Ablation Procedure

  Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)

  Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation

Secondary Outcomes (3)

• 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)]

• Number of Procedural Pauses During Left Atrial Instrumentation

  Study Day 1 for all patients, during left atrial ablation procedures using cryoablation

• Total Duration of Fluoroscopy Use

  Study Day 1 for all patients, during left atrial ablation procedures using cryoablation

Study Arms (1)

Esophageal warming

EXPERIMENTAL

Patients receive the Attune Medical Esophageal Heat Transfer Device

Device: Esophageal warming device (Attune Medical, Chicago, IL

Interventions

Esophageal warming device (Attune Medical, Chicago, IL DEVICE

Prospective, single center pilot stud

Esophageal warming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age over 18 years).
• Undergoing cryoablation for the treatment of atrial fibrillation, including pulmonary vein isolation.
• 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.

You may not qualify if:

• Patients who are unable to provide informed consent.
• Significant co-morbidities that preclude standard ablation procedure.
• Patients with \<40 kg of body mass.
• Patients with relevant esophageal pathology (e.g. esophageal cancer).

Sponsors & Collaborators

• Advanced Cooling Therapy, Inc., d/b/a Attune Medical: lead
• Winchester Medical Center: collaborator

Study Sites (1)

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rebekah Smith, RN, BSN
• Organization: Valley Health

rsmith3@valleyhealthlink.com

540-536-5547

Study Officials

• Daniel Alexander, MD

  Winchester Medical Center

  PRINCIPAL INVESTIGATOR

• Zachary Hollis, MD

  Winchester Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: September 30, 2019
• Primary Completion: July 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 12, 2022
• Results First Posted: September 5, 2021

Record last verified: 2022-03

Locations

US (1)