Atrial FibrillationNCT04087122
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
A study testing Esophageal warming device (Attune Medical, Chicago, IL in people with Atrial Fibrillation, run by Advanced Cooling Therapy, Inc., d/b/a Attune Medical at 1 site in United States.
Trial summary
Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. 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 warming device (Attune Medical, Chicago, IL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 31 Dec 2020
- 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
- Adult patients (age over 18 years).
- Undergoing cryoablation for the treatment of atrial fibrillation, including pulmonary vein isolation.
- Patients must be able to understand and critically review the informed consent form.
- Subjects must understand and agree to study requirements and sign a written informed consent.
Who cannot join
- Patients who are unable to provide informed consent.
- Significant co-morbidities that preclude standard ablation procedure.
- Patients with <40 kg of body mass.
- Patients with relevant esophageal pathology (e.g. esophageal cancer).
Trial locations and contacts
1 site in 1 country.
United States1 site
Winchester Medical Center
Winchester, Virginia, 22601
About this study
Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. Delivery of radiofrequency (RF) energy necessary to perform left atrial ablation has the potential to cause injury to the nearby esophagus including ulceration, hematoma, spasm, esophageal motility disorders, and, in the most extreme case, atrial-esophageal fistula.Esophageal mucosal lesions are the likely precursor to AEF, and esophageal mucosal lesions have been detected on post-ablation endoscopy after pulmonary vein isolation with an incidence ranging from 3% to 60%.
Active esophageal cooling during RF ablation as a means of esophageal injury prevention has been investigated through mathematical models, pre-clinical studies, and in clinical trials. Existing data support the efficacy of this approach, but the practice has not been widely adopted due to lack of a commercially available device.
The aim of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to warm the esophagus during left atrial cryoablation.
Read the detailed description
This study is a prospective, pilot study using the Attune Medical ensoETM esophageal heat transfer device to actively warm the esophagus during cryoablation procedures. This design is appropriate to gather the data needed regarding overall procedural time, compare this to historical controls, and estimate a sample size for a larger study powered for statistical significance.
Once patient consent is obtained, the subject will undergo preparation and anesthesia procedures following standard practice. Once the patient is intubated, the esophageal heat transfer device will be placed into the esophagus according to the IFU. The device will remain in place until the ablation procedure is completed and will be removed before extubation. Left atrial cryoablation using the standard approach will be performed with the ensoETM set at a temperature of 42 degrees C.
All patients will be followed up in total for 6 weeks (Long Term FU visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.
- Conditions
- Atrial Fibrillation
- Being tested
- Esophageal warming device (Attune Medical, Chicago, IL
- 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 warming device (Attune Medical, Chicago, ILDevice
Prospective, single center pilot stud
| Study group | Role | What they receive |
|---|---|---|
| Esophageal warming | Experimental | Patients receive the Attune Medical Esophageal Heat Transfer Device Receives: Device: Esophageal warming device (Attune Medical, Chicago, IL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Time of Active Ablation Procedure
Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
Measured: Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation
Secondary outcomes (3)
Total Procedure Time
Total procedure time from patient entry to Electrophysiology (EP) lab until discharge to Post-Anesthesia Care Unit (PACU)
Measured: Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)]
Number of Procedural Pauses During Left Atrial Instrumentation
Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
Measured: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation
Total Duration of Fluoroscopy Use
Total duration of fluoroscopy use during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
Measured: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start30 Sep 2019
- Primary completion30 Jul 2020
- Study completion31 Dec 2020
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winchester Medical Center
- Responsible party
- Sponsor
- Investigators
- Daniel Alexander, MD, Principal investigator, Winchester Medical CenterZachary Hollis, MD, Principal investigator, Winchester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087122
- Sponsor's protocol ID
- WMC-Cryo
- Status last verified
- Mar 2022
- First submitted
- 10 Sep 2019
- Last updated
- 12 May 2022
- 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 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
- ClinicalTrials.gov ID
- NCT04087122
- Acronym / sponsor ID
- WMC-Cryo
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Winchester Medical Center
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. Delivery of radiofrequency (RF) energy necessary to perform left atrial ablation has the potential to cause injury to the nearby esophagus including ulceration, hematoma, spasm, esophageal motility disorders, and, in the most extreme case, atrial-esophageal fistula.Esophageal mucosal lesions are the likely precursor to AEF, and esophageal mucosal lesions have been detected on post-ablation endoscopy after pulmonary vein isolation with an incidence ranging from 3% to 60%.
Active esophageal cooling during RF ablation as a means of esophageal injury prevention has been investigated through mathematical models, pre-clinical studies, and in clinical trials. Existing data support the efficacy of this approach, but the practice has not been widely adopted due to lack of a commercially available device.
The aim of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to warm the esophagus during left atrial cryoablation.
Detailed description
This study is a prospective, pilot study using the Attune Medical ensoETM esophageal heat transfer device to actively warm the esophagus during cryoablation procedures. This design is appropriate to gather the data needed regarding overall procedural time, compare this to historical controls, and estimate a sample size for a larger study powered for statistical significance.
Once patient consent is obtained, the subject will undergo preparation and anesthesia procedures following standard practice. Once the patient is intubated, the esophageal heat transfer device will be placed into the esophagus according to the IFU. The device will remain in place until the ablation procedure is completed and will be removed before extubation. Left atrial cryoablation using the standard approach will be performed with the ensoETM set at a temperature of 42 degrees C.
All patients will be followed up in total for 6 weeks (Long Term FU visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal warming | Experimental | Device: Esophageal warming device (Attune Medical, Chicago, ILPatients receive the Attune Medical Esophageal Heat Transfer Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age over 18 years).
- Undergoing cryoablation for the treatment of atrial fibrillation, including pulmonary vein isolation.
- Patients must be able to understand and critically review the informed consent form.
- Subjects must understand and agree to study requirements and sign a written informed consent.
Key exclusion criteria (4 listed)
- Patients who are unable to provide informed consent.
- Significant co-morbidities that preclude standard ablation procedure.
- Patients with <40 kg of body mass.
- Patients with relevant esophageal pathology (e.g. esophageal cancer).
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 warming device (Attune Medical, Chicago, ILProspective, single center pilot stud | Device | Esophageal warming |
Primary outcome
Total Time of Active Ablation Procedure
Time frame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation
Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
3 secondary outcomes
Total Procedure Time
Time frame: Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)]
Number of Procedural Pauses During Left Atrial Instrumentation
Time frame: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation
Total Duration of Fluoroscopy Use
Time frame: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
Daniel Alexander, MD principal investigator
Winchester Medical Center
Zachary Hollis, MD principal investigator
Winchester Medical Center
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 warming device (Attune Medical, Chicago, IL in people with Atrial Fibrillation, run by Advanced Cooling Therapy, Inc., d/b/a Attune Medical 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 4 inclusion and 4 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 12 May 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 5 Sep 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?
Total Time of Active Ablation Procedure (time frame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation). 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 12 May 2022.