Esophageal Cooling in Radiofrequency Cardiac Ablation

NCT03481023 | Completed Results FDA Device

• 1 other identifier: RMC # 186
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults. Half of participants will receive the EnsoETM in addition to RF ablation, while the other half will receive luminal esophageal temperature (LET) monitoring during RF ablation.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Esophageal Cooling Device; Radiofrequency Ablation; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Esophageal Mucosal Damage

  Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme. Higher scores on this scale indicate a worse outcome. The grading system is as follows: Grade 0: Normal Examination; Grade 1: Edema and Hypermia of the Mucosa; Grade 2a: Superficial ulceration, erosions, friability, blisters, exudates, hemorrhages, whitish membranes; Grade 2b: Grade 2a pluse deep discrete or circumferential ulcerations; Grade 3a: Small scattered areas of multiple ulceration and areas of necrosis with brown-black or greyish discoloration; Grade 3b: Extensive necrosis. For this grading scale we used the following scoring: 0=0 1=1 2a=2 2b=3 3a=4 3b=5

  The post-intervention outcome measure was performed within 1 day after Pulmonary Vein Isolation.

Secondary Outcomes (2)

• Number and Percentage of Participants With Treatment-Emergent Adverse Events [Safety and Adverse Events]

  3 months

• Presence of Esophageal Submucosal Damage, Indicated by Number of Ulcers as Assessed by Endoscopic Ultrasound (EUS)

  1 day

Study Arms (2)

Esophageal thermal regulation device

EXPERIMENTAL

Device: EnsoETM

LET monitoring

ACTIVE COMPARATOR

Procedure: Conventional Care

Interventions

EnsoETM DEVICE

Use of esophageal thermal regulation device during radiofrequency ablation.

Esophageal thermal regulation device

Conventional Care PROCEDURE

Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.

Also known as: LET monitoring

LET monitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has an atrial arrhythmia requiring radiofrequency ablation on the posterior aspect of the heart.
• Subject is willing and able to provide informed consent.
• Subject is capable of adhering to the expectations of the study protocol (e.g., attending follow-up visit).

You may not qualify if:

• Subject has known esophageal deformity, or evidence of esophageal trauma.
• Subject has prior radiation therapy involving the esophagus.
• Subject has a history of esophageal disease (e.g., esophageal varices, cirrhosis, history of esophagectomy, previous swallowing disorders, or achalasia).
• Subject has ingested acidic or caustic poisons.
• Subject is incarcerated.
• Subject is pregnant or plans to become pregnant.
• Subject has a silicone allergy.
• Subject has esophageal bleeding prior to surgical procedure.

Sponsors & Collaborators

• Riverside Medical Center: lead
• Attune Medical: collaborator

Study Sites (1)

Riverside Medical Center

Kankakee, Illinois, 60901, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Brad Suprenant
• Organization: Riverside Medical Center

blsuprenant@comcast.net

(815) 939-9400

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to which condition they were assigned; the Outcomes Assessor will be blinded to the hypotheses of the study as well as the condition to which the participant was assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 29, 2018
• Study Start: March 16, 2018
• Primary Completion: November 20, 2018
• Study Completion: December 20, 2018
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-02

Locations

US (1)