Esophageal DiseasesIMPACTNCT03819946
Improving Oesophageal Protection During AF Ablation
A study testing esophageal cooling device (Attune Medical, Chicago, IL) and Standard esophageal temperature probe in people with Esophageal Diseases, run by St. George's Hospital, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Diseases
- What is being tested?
- esophageal cooling device (Attune Medical, Chicago, IL) and Standard esophageal temperature probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St.George's Hospital
London, SW170QT
Mark M Gallagher, MD, +442087253701 ext. 3701, mark_m_gallagher@hotmail.com
Manav Sohal, PhD
About this study
Official title: Oesophageal Protection: a Novel Approach to Improving the Safety of Catheter Ablation for Atrial Fibrillation.
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.
Read the 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 catheter ablation procedure 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 4 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).
- Conditions
- Esophageal Diseases
- Being tested
- esophageal cooling device (Attune Medical, Chicago, IL), Standard esophageal temperature probe
- Keywords
- Esophageal protection, Ablation-related thermal injury, Catheter ablation for AF, Persistent AF ablation
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard esophageal temperature probeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard esophageal temperature probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 7 days
Secondary outcomes (3)
The incidence of esophageal symptoms after catheter ablation treatment.
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.
Measured: 3 months
• The incidence of major adverse outcomes (MACCE- major adverse cardiovascular cerebrovascular events) will be assessed.
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'.
Measured: 12 months
Long-term success rate of the catheter ablation procedure as measured from freedom from the treated arrhythmia (atrial fibrillation/atrial tachycardias).
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'.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. George's Hospital, London
- Sponsor type
- University, hospital or other
- Collaborators
- Attune Medical
- Responsible party
- Principal investigator, Dr. Mark M. Gallagher, St. George's Hospital, London
- Investigators
- Mark M Gallagher, MD, Principal investigator, St. George's Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819946
- Sponsor's protocol ID
- IRAS253844
- Acronym
- IMPACT
- Status last verified
- Dec 2019
- First submitted
- 20 Jan 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oesophageal Protection: a Novel Approach to Improving the Safety of Catheter Ablation for Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT03819946
- Acronym / sponsor ID
- IMPACT / IRAS253844
- Conditions
- Esophageal Diseases
- Keywords
- Esophageal protection, Ablation-related thermal injury, Catheter ablation for AF, Persistent AF ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St. George's Hospital, LondonUniversity, hospital or other
- Collaborators
- Attune Medical
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 catheter ablation procedure 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 4 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group- esophgeal cooling | Experimental | Device: esophageal cooling device (Attune Medical, Chicago, IL)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. |
| Control group- esophgeal temperature probe | Active comparator | Other: Standard esophageal temperature probeIn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Study Group- esophgeal cooling |
| Standard esophageal temperature probeIf 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. | Other | Control group- esophgeal temperature probe |
Primary outcome
• 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. 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.
3 secondary outcomes
The incidence of esophageal symptoms after catheter ablation treatment.
Time frame: 3 months
• The incidence of major adverse outcomes (MACCE- major adverse cardiovascular cerebrovascular events) will be assessed.
Time frame: 12 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark M Gallagher, MD principal investigator
St. George's Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophageal cooling device (Attune Medical, Chicago, IL) and Standard esophageal temperature probe in people with Esophageal Diseases, run by St. George's Hospital, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Hollingworth, Bsc (+4420287256606 ext. 6606, sahollin@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The incidence of catheter ablation related esophageal injury. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.