Atrial FibrillationNCT04659213
Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
A study testing esolution catheter in people with Atrial Fibrillation, run by S4 Medical at 1 site in United States.
Trial summary
To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- esolution catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Jul 2022
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age ≥ 22 years and < 80 years
- Clinical decision to proceed with AF ablation procedure.
- Ablation procedure to be completed with General Anesthesia
- Ablation procedure to be completed with use of radiofrequency catheter ablation
Who cannot join
- History of various esophageal pathology such as esophageal achalasia, varices, strictures, web, carcinoma, tumor/mass, scleroderma, Mallory-Weiss tear, Barrett's esophagitis, diverticulum, banding, laceration, perforation, balloon dilatation.
- Presence of a pH probe deployed in the esophagus
- Planned AF ablation procedure to be completed with laser energy or with cryo-energy
- Acute or uncontrolled psychiatric illness
- Unable to undergo upper endoscopy
- Enrollment in another FDA clinical trial
Show all 11Show fewer
- Unstable medical condition(s) that precludes safely completing study protocol
- Subject is incarcerated
- Subject is pregnant
- Subject is unable to comprehend the details of the study
- The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the investigational device procedure and study-related follow up visit requirements
Trial locations and contacts
1 site in 1 country.
About this study
To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
- Conditions
- Atrial Fibrillation
- Being tested
- esolution catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esolution catheterDevice
esolution is a catheter-based therapy designed to displace the esophagus away from the source of ablation energy during ablation of AF and to eliminate the risk of esophageal injury
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Placement of a luminal esophageal temperature probe (LET) and insertion of esolution esophageal retractor. In the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation Receives: Device: esolution catheter |
| Control Group | No intervention | Placement of a luminal esophageal temperature probe (LET) during RF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy
The primary study endpoint is the incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy
Measured: 15-72 hours post-ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Sep 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, multicenter, randomized controlled, double blinded clinical study to assess a reduction of esophageal lesions attributable to radiofrequency (RF) ablation with use of esolution (esophageal retractor) in comparison to conventional therapy (no use of an esophageal retractor). The randomization is with a 1:1 randomization scheme assigning consecutive patients who meet inclusion and exclusion criteria to either: placement of a luminal esophageal temperature probe(LET) (control group); or, to placement of a LET and insertion of esolution esophageal retractor (intervention group). In the control group, there will not be deviation of the esophagus and in the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation. All randomized subjects will be included in the intent-to-treat population, which will be used in the primary study analysis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- S4 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659213
- Sponsor's protocol ID
- EASY AF
- Status last verified
- Oct 2022
- First submitted
- 2 Dec 2020
- Last updated
- 31 Oct 2022
- Results posted
- No
- 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 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
- ClinicalTrials.gov ID
- NCT04659213
- Acronym / sponsor ID
- EASY AF
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- S4 MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 9 Dec 2020 (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.
To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, multicenter, randomized controlled, double blinded clinical study to assess a reduction of esophageal lesions attributable to radiofrequency (RF) ablation with use of esolution (esophageal retractor) in comparison to conventional therapy (no use of an esophageal retractor). The randomization is with a 1:1 randomization scheme assigning consecutive patients who meet inclusion and exclusion criteria to either: placement of a luminal esophageal temperature probe(LET) (control group); or, to placement of a LET and insertion of esolution esophageal retractor (intervention group). In the control group, there will not be deviation of the esophagus and in the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation. All randomized subjects will be included in the intent-to-treat population, which will be used in the primary study analysis.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Device: esolution catheterPlacement of a luminal esophageal temperature probe (LET) and insertion of esolution esophageal retractor. In the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation |
| Control Group | No intervention | –Placement of a luminal esophageal temperature probe (LET) during RF ablation |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female age ≥ 22 years and < 80 years
- Clinical decision to proceed with AF ablation procedure.
- Ablation procedure to be completed with General Anesthesia
- Ablation procedure to be completed with use of radiofrequency catheter ablation
Key exclusion criteria (11 listed)
- History of various esophageal pathology such as esophageal achalasia, varices, strictures, web, carcinoma, tumor/mass, scleroderma, Mallory-Weiss tear, Barrett's esophagitis, diverticulum, banding, laceration, perforation, balloon dilatation.
- Presence of a pH probe deployed in the esophagus
- Planned AF ablation procedure to be completed with laser energy or with cryo-energy
- Acute or uncontrolled psychiatric illness
- Unable to undergo upper endoscopy
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 |
|---|---|---|
| esolution catheteresolution is a catheter-based therapy designed to displace the esophagus away from the source of ablation energy during ablation of AF and to eliminate the risk of esophageal injury | Device | Interventional Group |
Primary outcome
Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy
Time frame: 15-72 hours post-ablation procedure
The primary study endpoint is the incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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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 esolution catheter in people with Atrial Fibrillation, run by S4 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 11 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 31 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy (time frame: 15-72 hours post-ablation procedure). 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 31 Oct 2022.