Atrial FibrillationEsoSureNCT02665442
Retracting the Esophagus During AF Ablation
A study testing Esophageal Stylet - EsoSure in people with Atrial Fibrillation and Esophageal Fistula, run by Northeast Scientific, Inc. at 1 site in United States.
Trial summary
This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Esophageal Fistula, Cardiac Arrhythmia
- What is being tested?
- Esophageal Stylet - EsoSure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above for the Patient or legal representative to provide informed consent.
- Documented paroxysmal or persistent Atrial Fibrillation by a Cardiologist and EKG finding.
- The patient will undergo Atrial Fibrillation catheter ablation as a treatment plan.
Who cannot join
- Bleeding disorder.
- Dysphagia to solid and liquid or any documented esophageal masses or cancer.
- Esophageal varices, diverticulum, esophageal web, upper GI bleeding, or hiatal hernia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
Medhat Abdelmessih, MD, 203-737-1330, medhat.abdelmessih@yale.edu
Mark Marieb, MD, FACC
About this study
Official title: Esophageal Stylet as a Strategy to Minimize the Risk of Esophageal Injury During the Atrial Fibrillation Catheter Ablation Procedure.
This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.
Read the detailed description
There is a clear potential to produce transmural esophageal injury during catheter ablation for AF when employing a lesion set targeting the posterior left atrial wall and pulmonary vein (PV) antra using contemporary large-tip or irrigated-tip catheter ablation systems when endocardial target sites are in close proximity to the esophagus.
It is very likely that a movement by the Esophageal Stylet of only 2 to 3 centimeters from the midline can safely protect the esophagus from thermal injury and will mimic the natural migration of the esophagus itself.
The Stylet proposes to safely facilitate lateral esophageal movement in a manner consistent with the esophagus's own natural migration in order to displace and maintain the esophagus's position away from potential damage resulting from a cardiac ablation procedure in the left atrium or coronary sinus.
The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters. Other common procedures, such as (Trans-esophageal Echocardiogram), move the esophagus twice this distance with a low risk.
- Conditions
- Atrial Fibrillation, Esophageal Fistula, Cardiac Arrhythmia
- Being tested
- Esophageal Stylet - EsoSure
- Keywords
- Esophageal Stylet, EsoSure, Atrial Fibrillation, Catheter Ablation, Mechanical esophageal displacement
- Medical subject headings
- Atrial Fibrillation, Esophageal Fistula, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal Stylet - EsoSureDevice
Also called Esophageal Retractor
The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters.
| Study group | Role | What they receive |
|---|---|---|
| Stylet | Experimental | This group will receive an Esophageal stylet; EsoSure during the ablation procedure in attempt of moving the esophagus away from the ablation site. Receives: Device: Esophageal Stylet - EsoSure |
| Non-Stylet | No intervention | This group will receive the ablation procedure without any modifications or interventions. No esophageal stylet will be used in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal injury or erosion
Decrease of esophageal thermal injury detected by esophageal Pill-Cam
Measured: 2-3 days post ablation
Secondary outcomes (2)
Recurrence of Atrial Fibrillation
Decrease of atrial fibrillation recurrence after 12 months
Measured: 12 Months
Total radiofrequency time
Decrease the total time of radiofrequency ablation at the procedure time
Measured: Day of ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeast Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Marieb, MD, FACC, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665442
- Sponsor's protocol ID
- 1511016760
- Acronym
- EsoSure
- Status last verified
- Jan 2016
- First submitted
- 23 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be shared through publications.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Stylet as a Strategy to Minimize the Risk of Esophageal Injury During the Atrial Fibrillation Catheter Ablation Procedure.
- ClinicalTrials.gov ID
- NCT02665442
- Acronym / sponsor ID
- EsoSure / 1511016760
- Conditions
- Atrial Fibrillation, Esophageal Fistula, Cardiac Arrhythmia
- Keywords
- Esophageal Stylet, EsoSure, Atrial Fibrillation, Catheter Ablation, Mechanical esophageal displacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northeast Scientific, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- 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.
This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.
Detailed description
There is a clear potential to produce transmural esophageal injury during catheter ablation for AF when employing a lesion set targeting the posterior left atrial wall and pulmonary vein (PV) antra using contemporary large-tip or irrigated-tip catheter ablation systems when endocardial target sites are in close proximity to the esophagus.
It is very likely that a movement by the Esophageal Stylet of only 2 to 3 centimeters from the midline can safely protect the esophagus from thermal injury and will mimic the natural migration of the esophagus itself.
The Stylet proposes to safely facilitate lateral esophageal movement in a manner consistent with the esophagus's own natural migration in order to displace and maintain the esophagus's position away from potential damage resulting from a cardiac ablation procedure in the left atrium or coronary sinus.
The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters. Other common procedures, such as (Trans-esophageal Echocardiogram), move the esophagus twice this distance with a low risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stylet | Experimental | Device: Esophageal Stylet - EsoSureThis group will receive an Esophageal stylet; EsoSure during the ablation procedure in attempt of moving the esophagus away from the ablation site. |
| Non-Stylet | No intervention | –This group will receive the ablation procedure without any modifications or interventions. No esophageal stylet will be used in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or above for the Patient or legal representative to provide informed consent.
- Documented paroxysmal or persistent Atrial Fibrillation by a Cardiologist and EKG finding.
- The patient will undergo Atrial Fibrillation catheter ablation as a treatment plan.
Key exclusion criteria (3 listed)
- Bleeding disorder.
- Dysphagia to solid and liquid or any documented esophageal masses or cancer.
- Esophageal varices, diverticulum, esophageal web, upper GI bleeding, or hiatal hernia.
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 Stylet - EsoSureAlso: Esophageal RetractorThe Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters. | Device | Stylet |
Primary outcome
Esophageal injury or erosion
Time frame: 2-3 days post ablation
Decrease of esophageal thermal injury detected by esophageal Pill-Cam
2 secondary outcomes
Recurrence of Atrial Fibrillation
Time frame: 12 Months
Total radiofrequency time
Time frame: Day of ablation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Individual participant dataSharing planned: Yes. Data will be shared through publications.
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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 Marieb, MD, FACC principal investigator
Yale University
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 Stylet - EsoSure in people with Atrial Fibrillation and Esophageal Fistula, run by Northeast Scientific, Inc. 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 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 27 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medhat Abdelmessih, MD ((203) 737-1330, medhat.abdelmessih@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal injury or erosion (time frame: 2-3 days post ablation). 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 27 Jan 2016; AzTrials last refreshed its copy on 30 Oct 2026.