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Improving Oesophageal Protection During AF Ablation (IMPACT)

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ClinicalTrials.gov Identifier: NCT03819946
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Attune Medical
Information provided by (Responsible Party):
Dr. Mark M. Gallagher, St. George's Hospital, London

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 a few 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. 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 compared to controls, after an extensive catheter ablation procedure for the treatment of AF.


Condition or disease Intervention/treatment Phase
Oesophageal Disease Device: esophageal cooling device (Attune Medical, Chicago, IL) Other: Standard esophageal temperature probe Not Applicable

Detailed Description:

Overall design This is a randomized controlled trial with 1:1 randomization to study or control group.

Treatment/intervention plan and rationale AF patients awaiting to have a planned extensive catheter ablation procedure (or AF ablation procedure where the planned protocol may highlight them as being at higher risk of surrounding structural trauma) as their treatment will be eligible for this study. If they participate, there is a 1:1 randomization to study or control group.

The study group will have their catheter ablation procedure with utilization of esophageal protection using the cooling tubing device (Attune Medical, Chicago IL). The cooling is controlled by the procedural doctor, with temperatures set in the range of patient safety (for example, cooling at 25 degrees). This device is already in use clinically albeit in a different clinical setting. The device is currently used an intensive care setting to provide whole body cooling. It is designed to be inserted into the esophagus. The temperature control does not allow temperatures to go into the extremes, so preserving patient safety.

The control group will have their catheter ablation procedure using standard esophageal protection methods, which is an esophageal temperature probe, to measure for any temperature changes during application of ablation energy. If measured esophageal temperatures reach beyond 38 degrees then ablation is halted in that area.

Follow up endoscopy assessment After the ablation procedure, a follow up upper GI endoscopy test will be performed to review for any ablation-related thermal injury, by a group of endoscopists who are 'blinded' to the randomization of the participant. The follow up endoscopy test will be confirmed with the participant and the timing of this follow up test is within 1 week of their catheter ablation procedure.

Clinic follow up The clinic follow up will remain exactly the same as standard care but at the first clinic (this is 12 weeks or 3 months from the ablation procedure) we will review or ask about any lingering gastro-esophageal symptoms and record this in a basic questionnaire (the GerdQ questionnaire will be used).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: The endoscopists performing the follow up endoscopy test will be 'blinded' to the randomization of the trial participant, to minimise bias.
Primary Purpose: Prevention
Official Title: Oesophageal Protection: a Novel Approach to Improving the Safety of Catheter Ablation for Atrial Fibrillation.
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group- esophgeal cooling
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)
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.

Active Comparator: Control group- esophgeal temperature probe
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
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.




Primary Outcome Measures :
  1. • The incidence of catheter ablation related esophageal injury. [ Time Frame: 7 days ]
    The incidence of catheter ablation related esophageal injury will be assessed by endoscopic examination. The injury scale is graded 0-4. 4 being the worst score indicating severe esophageal injury.


Secondary Outcome Measures :
  1. The incidence of esophageal symptoms after catheter ablation treatment. [ Time Frame: 3 months ]
    During clinic assessment follow up, the participant will fill out a reflux symptoms questionnaire. This is called the GerdQ questionnaire (GerdQ stands for: gastro-esophageal reflux disease questionnaire). This is a scoring system of range 0-18, a score of 18 being the worst symptoms outcome.

  2. • The incidence of major adverse outcomes (MACCE- major adverse cardiovascular cerebrovascular events) will be assessed. [ Time Frame: 12 months ]
    The major adverse events recorded includes the risk of cerebrovascular accident, transient ischaemic attacks (TIA) and myocardial infarction (MI). For each condition in this MACCE category- the recorded response will either be 'yes' or 'no' or 'positive' or 'negative'.

  3. Long-term success rate of the catheter ablation procedure as measured from freedom from the treated arrhythmia (atrial fibrillation/atrial tachycardias). [ Time Frame: 12 months ]
    During clinic follow up, Holter monitors (ambulatory ECG monitors) or implantable loop recorders will monitor for any recurrence of the treated arrhythmia. Any recurrence will be recorded to assess longterm success of the catheter ablation treatment (this is objectively measured at 12 months). The outcome response is recorded as either 'yes' or 'no'.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Any AF patient planned for an extensive catheter ablation procedure or a type of ablation protocol that puts them at higher risk of surrounding structural trauma

Exclusion Criteria:

  • 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 ablation procedures not needing oesophageal protection.
  • Patients at high risk of oesophageal bleeding e.g. oesophageal varices.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819946


Contacts
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Contact: Anu Taiwo, Bsc +4420287256606 ext 6606 mtaiwo@sgul.ac.uk

Locations
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United Kingdom
St.George's Hospital Not yet recruiting
London, United Kingdom, SW170QT
Contact: Mark M Gallagher, MD    +442087253701 ext 3701    mark_m_gallagher@hotmail.com   
Sub-Investigator: Manav Sohal, PhD         
Sub-Investigator: Abhay Bajpai, MD         
Sub-Investigator: Zia Zuberi, PhD         
Sub-Investigator: Anthony Li, MD         
Sub-Investigator: Mark Norman, PhD         
Sponsors and Collaborators
St. George's Hospital, London
Attune Medical
Investigators
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Principal Investigator: Mark M Gallagher, MD St. George's Hospital NHS Foundation Trust

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Responsible Party: Dr. Mark M. Gallagher, Clinical Lead for Cardiac Electrophysiology and Principal Investigator, St. George's Hospital, London
ClinicalTrials.gov Identifier: NCT03819946     History of Changes
Other Study ID Numbers: IRAS253844
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be anonymised and stored securely in the institutional secured electronic database network. During the study, the data will be available to site sub-investigators only.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Mark M. Gallagher, St. George's Hospital, London:
Oesophageal protection
Ablation-related thermal injury
Catheter ablation for AF
Persistent AF ablation

Additional relevant MeSH terms:
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Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases