Improving Oesophageal Protection During AF Ablation

NCT03819946 | Unknown DMC

• 1 other identifier: IRAS253844
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Catheter ablation is an established treatment for atrial fibrillation (AF). For those with the more longstanding form of the condition and are graded as longstanding persistent AF, catheter ablation techniques often involve an extensive ablative protocol. This often includes application of ablation energy to the posterior left atrial wall. The left atrial (LA) wall is only on average 5 millimetres away from the esophageal wall. It has been shown that ablation to the posterior LA wall can cause thermal injury to the esophageal wall. Even those that require pulmonary vein isolation only can be at risk of esophageal injury. This injury can impact on patient symptoms as well as increase the risk of an atrio-esophageal fistula being formed. Esophageal protection methods during catheter ablation for AF in current practice is very limited and investigation towards improved approaches, in the form of a randomized clinical trial is required. The aim or purpose of this research project is to study the effect of esophageal cooling on the incidence of esophageal thermal injury (endoscopy-graded esophageal epithelial lesions and/or the presence of ablation-related gastroparesis with patient symptoms) compared to controls, after a catheter ablation procedure for the treatment of AF.

Conditions

Esophageal Diseases

Keywords

Esophageal protection; Ablation-related thermal injury; Catheter ablation for AF; Persistent AF ablation

Outcome Measures

Primary Outcomes (1)

• • The incidence of catheter ablation related esophageal injury.

  The incidence of catheter ablation related esophageal injury will be assessed by endoscopic examination. Evidence of thermal injury or symptomatic gastroparesis will be recorded. The thermal injury scale is graded 0-6. 6 being the worst score indicating severe esophageal injury. Endoscopic evidence of gastroparesis is dictated by presence of significant food residue despite \>6 hours of fasting and must be correlated with new patient symptoms post-ablation.

  7 days

Secondary Outcomes (3)

• The incidence of esophageal symptoms after catheter ablation treatment.

  3 months

• • The incidence of major adverse outcomes (MACCE- major adverse cardiovascular cerebrovascular events) will be assessed.

  12 months

• Long-term success rate of the catheter ablation procedure as measured from freedom from the treated arrhythmia (atrial fibrillation/atrial tachycardias).

  12 months

Study Arms (2)

Study Group- esophgeal cooling

EXPERIMENTAL

In this study arm, the participants will have esophageal protection during their catheter ablation procedure, utilizing the esophageal cooling device (Attune Medical, Chicago, IL). During catheter ablation, the cooling device is set to cooling levels.

Device: esophageal cooling device (Attune Medical, Chicago, IL)

Control group- esophgeal temperature probe

ACTIVE COMPARATOR

In this control group, the participants will have esophageal protection utilizing the standard method in current practice, which is an esophageal temperature probe. If recorded temperatures rise above 38 degrees during ablation, ablation treatment is halted in this region.

Other: Standard esophageal temperature probe

Interventions

esophageal cooling device (Attune Medical, Chicago, IL) DEVICE

The esophageal cooling device is a silicone soft tubing that is designed to be inserted into the esophagus. It is currently used clinically to provide whole body cooling or temperature control for intensive care patients (in medically induced coma or general anesthesia). The tubing is established but not been used in the clinical setting of catheter ablation for AF (which is performed under general anesthesia). During application of ablation energy to the posterior left atrial wall, the tubing is cooled to medium-low levels (25 degrees) and this is controlled by the operator.

Study Group- esophgeal cooling

Standard esophageal temperature probe OTHER

If the participant is randomized to the control group, then a standard esophageal protection method will be used during their catheter ablation procedure. This comprises of an esophageal temperature probe, inserted whilst the patient is under general anesthesia. If during application of ablation treatment to the posterior left atrial wall causes the esophageal temperature to rise above 38 degrees the ablation treatment is halted in this region. If ablation treatment is incomplete, re-application can be applied again cautiously if temperatures fall back to 37 degrees. Further temperature rise of over 38 degrees at the same region is a contra-indication to further ablation work here.

Control group- esophgeal temperature probe

Eligibility Criteria

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

You may qualify if:

• Any AF patient planned for a catheter ablation procedure or a left atrial ablation protocol that puts them at risk of surrounding structural trauma, including oesophageal injury.

You may not qualify if:

• Patients at the age extremities will not be approached for the study. (Paediatric patients or young adults (\<aged 18) or older adults over the age of 85)
• Patients having simple or non-left atrial ablation procedures not needing oesophageal protection.
• Patients at high risk of oesophageal bleeding e.g. oesophageal varices.

Sponsors & Collaborators

• St. George's Hospital, London: lead
• Attune Medical: collaborator

Study Sites (1)

St.George's Hospital

London, SW170QT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mark M Gallagher, MD

  St. George's Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Hollingworth, Bsc

CONTACT

+4420287256606; sahollin@sgul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The endoscopists performing the follow up endoscopy test will be 'blinded' to the randomization of the trial participant, to minimise bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lead for Cardiac Electrophysiology and Principal Investigator

Model Details: This is a randomized clinical trial with 1:1 randomization to the study protocol or the control. The study group will have esophageal protection utilising the esophageal cooling device. The control group will have standard esophageal protection, using an esophageal temperature probe.

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 29, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)