Atrial FibrillationNCT03481023
Esophageal Cooling in Radiofrequency Cardiac Ablation
A study testing EnsoETM and Conventional Care in people with Atrial Fibrillation, run by Riverside Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- EnsoETM and Conventional Care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esophageal Cooling in Radiofrequency Cardiac Ablation: Pilot Study
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.
Read the detailed description
Study Specific Procedures:
- Study specific imaging will include endoscopic evaluation of the esophagus one day before surgery at the time of the pre-op Transesophageal Echocardiography (TEE) and again 1-day post-op. This will include endoscopic esophageal intubation with visual assessment of the entire esophagus and grading of lesions. Coupled with this procedure will include endoscopic ultrasound assessment of the esophagus at the level of the left atrium with specific attention to the sub-mucosal layer that separates esophagus from the cardiac tissue. The patient will undergo moderate sedation during this procedure, which will accompany the TEE.
- The Esophageal Cooling Device (ECD) will be placed by trained study staff following endotracheal intubation. Proper positioning will be verified. A temperature probe will be placed to verify the patients core temperature. The target temperature will be set to the core temperature at the beginning of the procedure. Two minutes prior to ablation on the posterior wall the target temperature will be changed to the minimum temperature setting which will allow for maximal cooling. Cooling will take place throughout the duration of posterior wall ablation. After ablation in this territory is complete the target temperature will return to the patients core temperature. The device will be removed at the completion of the procedure by anesthesiology when there is no further need for an orogastric tube.
- LET monitoring will not be performed in the patients of the intervention group as the ECD is prohibitive. Therefore, ice lavage of the esophagus, as detailed below, will not be performed in this group.
Standard Care Procedures:
- Medical History will be obtained by interview and will involve identification of contraindications to the use of the ECD. This includes a history of esophageal perforation or varices. An allergy to silicone will be assessed.
- The patient's active medication list will be reviewed as is standard protocol for atrial fibrillation ablation, but this is not specific to the study as there are no medications that would impact the use of the ECD.
- All subjects will be on Protonix (40mg; twice daily) immediately following surgery for 30 days and anticoagulation for 3 months following surgery.
- The physical exam will be performed. Study specific exam is included as part of the airway assessment which is performed on a regular basis by anesthesiology. The oropharynx will be assessed prior to placement of the ECD.
- Radiofrequency ablation involving the posterior aspect of the left atrium will be performed with standard LET monitoring which may include intermittent boluses of iced lavaged saline through the nasogastric tube when the temperature rises above 1 degree centigrade. Termination of atrial fibrillation with provocation testing will be completed and further atrial tachyarrhythmia ablation will be carried out as indicated.
- The patient will follow-up in the office based on standard procedure with 10 day and 3 month follow-up to be scheduled.
- Conditions
- Atrial Fibrillation
- Being tested
- EnsoETM, Conventional Care
- Keywords
- Atrial Fibrillation, Esophageal Cooling Device, Radiofrequency Ablation, Arrhythmia
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsoETMDevice
Use of esophageal thermal regulation device during radiofrequency ablation.
Conventional CareProcedure or surgery
Also called LET monitoring
Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal thermal regulation device | Experimental | Not described Receives: Device: EnsoETM |
| LET monitoring | Active comparator | Not described Receives: Procedure: Conventional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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]
Measured: 3 months
Presence of Esophageal Submucosal Damage, Indicated by Number of Ulcers as Assessed by Endoscopic Ultrasound (EUS)
Altered submucosal tissue architecture as assessed by endoscopic ultrasound (EUS)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start16 Mar 2018
- Primary completion20 Nov 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riverside Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Attune Medical
- Responsible party
- Principal investigator, Brad Suprenant, Riverside Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481023
- Sponsor's protocol ID
- RMC # 186
- Status last verified
- Feb 2024
- First submitted
- 20 Mar 2018
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Cooling in Radiofrequency Cardiac Ablation: Pilot Study
- ClinicalTrials.gov ID
- NCT03481023
- Acronym / sponsor ID
- RMC # 186
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Esophageal Cooling Device, Radiofrequency Ablation, Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Riverside Medical CenterUniversity, hospital or other
- Collaborators
- Attune Medical
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Specific Procedures:
- Study specific imaging will include endoscopic evaluation of the esophagus one day before surgery at the time of the pre-op Transesophageal Echocardiography (TEE) and again 1-day post-op. This will include endoscopic esophageal intubation with visual assessment of the entire esophagus and grading of lesions. Coupled with this procedure will include endoscopic ultrasound assessment of the esophagus at the level of the left atrium with specific attention to the sub-mucosal layer that separates esophagus from the cardiac tissue. The patient will undergo moderate sedation during this procedure, which will accompany the TEE.
- The Esophageal Cooling Device (ECD) will be placed by trained study staff following endotracheal intubation. Proper positioning will be verified. A temperature probe will be placed to verify the patients core temperature. The target temperature will be set to the core temperature at the beginning of the procedure. Two minutes prior to ablation on the posterior wall the target temperature will be changed to the minimum temperature setting which will allow for maximal cooling. Cooling will take place throughout the duration of posterior wall ablation. After ablation in this territory is complete the target temperature will return to the patients core temperature. The device will be removed at the completion of the procedure by anesthesiology when there is no further need for an orogastric tube.
- LET monitoring will not be performed in the patients of the intervention group as the ECD is prohibitive. Therefore, ice lavage of the esophagus, as detailed below, will not be performed in this group.
Standard Care Procedures:
- Medical History will be obtained by interview and will involve identification of contraindications to the use of the ECD. This includes a history of esophageal perforation or varices. An allergy to silicone will be assessed.
- The patient's active medication list will be reviewed as is standard protocol for atrial fibrillation ablation, but this is not specific to the study as there are no medications that would impact the use of the ECD.
- All subjects will be on Protonix (40mg; twice daily) immediately following surgery for 30 days and anticoagulation for 3 months following surgery.
- The physical exam will be performed. Study specific exam is included as part of the airway assessment which is performed on a regular basis by anesthesiology. The oropharynx will be assessed prior to placement of the ECD.
- Radiofrequency ablation involving the posterior aspect of the left atrium will be performed with standard LET monitoring which may include intermittent boluses of iced lavaged saline through the nasogastric tube when the temperature rises above 1 degree centigrade. Termination of atrial fibrillation with provocation testing will be completed and further atrial tachyarrhythmia ablation will be carried out as indicated.
- The patient will follow-up in the office based on standard procedure with 10 day and 3 month follow-up to be scheduled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esophageal thermal regulation device | Experimental | Device: EnsoETM |
| LET monitoring | Active comparator | Procedure: Conventional Care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| EnsoETMUse of esophageal thermal regulation device during radiofrequency ablation. | Device | Esophageal thermal regulation device |
| Conventional CareAlso: LET monitoringUse of luminal esophageal temperature monitoring during radiofrequency ablation procedure. | Procedure or surgery | LET monitoring |
Primary outcome
Esophageal Mucosal Damage
Time frame: The post-intervention outcome measure was performed within 1 day after Pulmonary Vein Isolation.
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
2 secondary outcomes
Number and Percentage of Participants With Treatment-Emergent Adverse Events [Safety and Adverse Events]
Time frame: 3 months
Presence of Esophageal Submucosal Damage, Indicated by Number of Ulcers as Assessed by Endoscopic Ultrasound (EUS)
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnsoETM and Conventional Care in people with Atrial Fibrillation, run by Riverside Medical Center at 1 site in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 States. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Mucosal Damage (time frame: The post-intervention outcome measure was performed within 1 day after Pulmonary Vein Isolation.). 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 28 Feb 2024.