Atrial FibrillationeCoolAFNCT03691571
Esophageal Cooling for AF Ablation
A study testing Esophageal Cooling in people with Atrial Fibrillation, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Esophageal Cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2018to 28 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above the age of 18 years old.
- Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
- Patients must be able to understand and critically review the informed consent form.
Who cannot join
- Patients whom are unable to provide informed consent.
- Patients with contraindication to EGD.
- History of prior AF ablation procedures.
- Significant co-morbidities that preclude standard ablation procedure.
- Patient is ineligible for EnsoETM placement due to:
- Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
- Known ingestion of acidic or caustic poisons within the prior 24 hours.
- Patients with <40 kg of body mass.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania - Perelman Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
Read the detailed description
The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.
- Conditions
- Atrial Fibrillation
- Being tested
- Esophageal Cooling, Control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal CoolingDevice
Also called Attune Medical Esophageal Heat Transfer Device, EnsoETM
The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage.
ControlDevice
Also called Standard of care
Standard of care involves standard temperature probe monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal Cooling | Experimental | Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). Receives: Device: Esophageal Cooling |
| Control | Active comparator | Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants With Esophageal Thermal Injury
Any injury, occurrence rate measured by EGD
Measured: Day 1 to 2
Number and Percentage of Participants With Esophageal Injury Based on Severity
The severity of injury measured by EGD
Measured: Day 1 to 2
Secondary outcomes (3)
Posterior Wall Ablation Parameters: Temperature
Catheter Temperature
Measured: Day 0
Posterior Wall Ablation Parameters
Impedance drop (absolute difference)
Measured: Day 0
Occurrence of Acute PV Reconnection
Number of Participants with Acute PV Reconnection
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start11 Oct 2018
- Primary completion25 Mar 2020
- Study completion28 Feb 2021
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Randomized, blinded single center pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Attune Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691571
- Sponsor's protocol ID
- 831401
- Acronym
- eCoolAF
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2018
- Last updated
- 5 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)
- ClinicalTrials.gov ID
- NCT03691571
- Acronym / sponsor ID
- eCoolAF / 831401
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Attune Medical
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Posted 21 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
Detailed description
The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, blinded single center pilot study
| Arm | Type | Receives |
|---|---|---|
| Esophageal Cooling | Experimental | Device: Esophageal CoolingPatients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). |
| Control | Active comparator | Device: ControlPatients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients above the age of 18 years old.
- Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
- Patients must be able to understand and critically review the informed consent form.
Key exclusion criteria (8 listed)
- Patients whom are unable to provide informed consent.
- Patients with contraindication to EGD.
- History of prior AF ablation procedures.
- Significant co-morbidities that preclude standard ablation procedure.
- Patient is ineligible for EnsoETM placement due to:
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 CoolingAlso: Attune Medical Esophageal Heat Transfer Device, EnsoETMThe EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. | Device | Esophageal Cooling |
| ControlAlso: Standard of careStandard of care involves standard temperature probe monitoring. | Device | Control |
Primary outcome
Number and Percentage of Participants With Esophageal Thermal Injury
Time frame: Day 1 to 2
Any injury, occurrence rate measured by EGD
Number and Percentage of Participants With Esophageal Injury Based on Severity
Time frame: Day 1 to 2
The severity of injury measured by EGD
3 secondary outcomes
Posterior Wall Ablation Parameters: Temperature
Time frame: Day 0
Posterior Wall Ablation Parameters
Time frame: Day 0
Occurrence of Acute PV Reconnection
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- 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 Esophageal Cooling in people with Atrial Fibrillation, run by University of Pennsylvania 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 5 Oct 2022. 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 21 Dec 2021). 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?
Number and Percentage of Participants With Esophageal Thermal Injury (time frame: Day 1 to 2). The study lists 2 primary outcomes in all. 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 5 Oct 2022.