Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)

NCT04079634 | Completed Results FDA Device

• 1 other identifier: STU00209610
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 cryoballoon ablation of atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Esophageal Thermal Injury

  Endoscopic evidence of thermal injury

  Post-Procedure Day 1

Study Arms (2)

Treatment

EXPERIMENTAL

Placement of study device (EnsoETM) for temperature management

Device: Esophageal warming

Control

ACTIVE COMPARATOR

Placement of standard temperature probe

Device: Control

Interventions

Esophageal warming DEVICE

Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure

Treatment

Control DEVICE

Standard temperature probe monitoring

Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Attune Medical: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, 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: Nishant Verma, MD
• Organization: Northwestern University

nishant.verma@nm.org

3129262148

Study Officials

• Nishant Verma, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not be informed if they were randomized to control or treatment until Month 2 follow-up visit.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: October 8, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2022
• Last Updated: May 16, 2023
• Results First Posted: May 16, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Within one year of enrollment closure
• Access Criteria: Consent will be posted to ClinicalTrials.Gov

Locations

US (1)