Esophageal Protection Study: A Multicenter Study

NCT04577859 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 851998
• Study Type: interventional
• Target: 152
• Locations: 2 countries
• Sites: 6

Brief Summary

Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the esophagus caused by thermal energy being transmitted to the esophagus from the heart. The esophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe esophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In recent studies, it was shown that a more advanced type of esophageal probe (ensoETM) that cools the esophagus during ablation is better at protecting the esophagus from ablation-related injury compared to the standard care temperature monitoring probe currently used. The ensoETM is a CE marked and FDA-cleared device, with an intended purpose of controlling patient temperature and has received marketing authorization from FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. The purpose of this study is to determine if the long-term efficacy outcome results obtained in single pilot studies can be replicated in a prospective, multi-center randomized controlled trail comparing the the esophageal cooling probe versus a standard of care esophageal temperature monitoring probe. There is a 50:50 chance of the esophageal cooling probe being used during AF ablation for participants.

Conditions

AF - Atrial Fibrillation; Complication; Atrio-Esophageal Fistula

Keywords

AF ablation; Radiofrequency; Esophageal thermal injury; atrio-esophageal fistula; Esophageal protection; Esophageal cooling; Esophageal temperature monitoring probe

Outcome Measures

Primary Outcomes (1)

• Freedom from the treated atrial arrhythmia

  Record any evidence of return of the treated arrhythmia at follow up cardiac monitoring: includes, 12 lead ECG, Holter, implantable loop recorders, non-invasive ECG monitors, mobile ECG apps. A return of AF (treated arrhythmia) must satisfy clear ECG/monitoring evidence of AF/related AT for \>30 seconds. This is a measure of the success of the AF ablation procedure.

  Measured at these time points: 3, 6, 12, months from time of ablation procedure.

Secondary Outcomes (6)

• Procedure duration (minutes).

  Measured once. At time of AF ablation procedure (day 0)

• Fluoroscopy duration (minutes)

  Measured once. At time of AF ablation procedure (day 0)

• Incidence of major adverse events (MACCE) at times 0, 3, 6, 12 months.

  Measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.

• Ability to attain procedural endpoints during AF ablation.

  Measured once at time points: time of AF ablation procedure (day 0).

• Incidence of clinically significant chest/gastroenterological symptoms post ablation

  Measured once at time points: 3 months from AF ablation procedure

Study Arms (2)

Study group

ACTIVE COMPARATOR

Those randomized to the study group will receive the esophageal cooling device- the ensoETM probe, during AF ablation treatment, under general anaesthetic. The cooling device is set to 4 degrees Celsius during ablation of the left atrial posterior wall.

Device: ensoETM. Esophageal cooling during AF ablation

Control group

ACTIVE COMPARATOR

Those randomized to the control group will receive standard of care, which is an esophageal temperature monitoring probe during their AF ablation procedure, under general anesthetic. The esophageal temperature probe is placed close to the level of ablation (the probe should be at the esophageal level where, opposite this, the ablation catheter is at, in the endocardial aspect of the posterior left atrium).

Device: Esophageal temperature monitoring probe

Interventions

ensoETM. Esophageal cooling during AF ablation DEVICE

Esophageal cooling during AF ablation: The ensoETM probe is inserted via the orogastric route when the patient is under general anesthesia. The device is set to cool during ablation of the posterior aspect of the left atrium, to protect against transmitted thermal energy and so reduce or prevent esophageal thermal injury.

Study group

Esophageal temperature monitoring probe DEVICE

An esophageal temperature monitoring probe is a typical monitoring device used in standard of care AF ablations. This allows any temperature rise in the esophagus to be detected during ablation. If the temperature reaches \>38 degrees then it is widely recognized that ablation should be halted until the temperatures fall back to below 38 degrees. It therefore has the ability to detect esophageal temperature rise only.

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AF patients scheduled to have a radiofrequency AF ablation procedure under general anesthesia who pass standard care screening assessments.

You may not qualify if:

• Inability to consent for any reason.
• Those in extremities of age (\<18 or \>85) will not be recruited.
• AF patients scheduled to have a radiofrequency AF ablation under local anesthesia
• Patients who have received a left atrial ablation procedure within the last 90 days. • • Patients enrolled in another clinical trial that might impact participation in this trial.
• \*\* For patients electing to undergo the optional endoscopy, no contraindications to endoscopy should be present

Sponsors & Collaborators

• Advanced Cooling Therapy LLC, d/b/a Attune Medical: lead
• University of Pennsylvania: collaborator
• Berry Consultants: collaborator
• Texas Cardiac Arrhythmia Research Foundation: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Kansas City Cardiac Arrhythmia Research LLC: collaborator

Study Sites (6)

NCH Research Institute

Naples, Florida, 34102, United States

Location

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas, 66211, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

St.George's Hospital

London, SW170QT, United Kingdom

Location

Related Publications (5)

• Leung LW, Gallagher MM, Santangeli P, Tschabrunn C, Guerra JM, Campos B, Hayat J, Atem F, Mickelsen S, Kulstad E. Esophageal cooling for protection during left atrial ablation: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2020 Nov;59(2):347-355. doi: 10.1007/s10840-019-00661-5. Epub 2019 Nov 22.

  PMID: 31758504 BACKGROUND

• Leung LW, Gallagher MM. Esophageal cooling for protection: an innovative tool that improves the safety of atrial fibrillation ablation. Expert Rev Med Devices. 2020 Oct;17(10):981-982. doi: 10.1080/17434440.2020.1824674. Epub 2020 Sep 21.

  PMID: 32933326 BACKGROUND

• Leung LWM, Gallagher MM. Letter in reply to Gianni et al on "Prevention, diagnosis, and management of atrioesophageal fistula". Pacing Clin Electrophysiol. 2020 Nov;43(11):1417-1418. doi: 10.1111/pace.14012. Epub 2020 Sep 3. No abstract available.

  PMID: 32662530 BACKGROUND

• Zagrodzky J, Gallagher MM, Leung LWM, Sharkoski T, Santangeli P, Tschabrunn C, Guerra JM, Campos B, MacGregor J, Hayat J, Clark B, Mazur A, Feher M, Arnold M, Metzl M, Nazari J, Kulstad E. Cooling or Warming the Esophagus to Reduce Esophageal Injury During Left Atrial Ablation in the Treatment of Atrial Fibrillation. J Vis Exp. 2020 Mar 15;(157). doi: 10.3791/60733.

  PMID: 32225140 BACKGROUND

• Bir LS, Kuruoglu HR. Jitter measurement by axonal microstimulation in cervical radiculopathy. Muscle Nerve. 1998 Nov;21(11):1563-4. doi: 10.1002/(sici)1097-4598(199811)21:113.0.co;2-z. No abstract available.

  PMID: 9771690 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• David Callans, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant is blinded to which esophageal probe is used (Esophageal cooling probe, \[ensoETM\] versus esophageal temperature monitoring probe) during their AF ablation, which is performed under general anesthesia. This study includes an optional endoscopy. The endoscopist who performs the upper GI (gastrointestinal) endoscopy camera after the ablation procedure, is also blinded to the randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, prospective double-blind 1:1 randomized clinical trial

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: March 10, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); GB (1)