Esophageal DeviationNCT01546168
Deviating the Esophagus in Atrial Fibrillation Ablation
A study testing esophageal deviation with IDE device in people with Esophageal Deviation and Atrial Fibrillation, run by Vivek Reddy at 4 sites in United States.
Trial summary
In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Deviation, Atrial Fibrillation, Ablation
- What is being tested?
- esophageal deviation with IDE device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2011to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 - Age < 80 yr
- Documentation of atrial fibrillation (AF)
- Referred for a first ever ablation procedure for AF (prior ablation of right-sided Typical flutter, or "limited" left-sided of an accessory pathway are permitted)
- General anesthesia
- All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.
Who cannot join
- Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
- INR > 4.0 at the time of the procedure
- H/o of severe esophageal ulcers, strictures, esophagitis or GERD
- H/o Esophageal Surgery
- Prior surgical or catheter ablation procedure for AF (except right atrial flutter ablation)
- Any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram
Show all 10Show fewer
- Significant abnormality on Swallowing Impairment Score
- Mental impairment precluding signing consent or completing follow up
- Patients with any other significant uncontrolled or unstable medical condition
- Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78075
Massachusetts General Hospital
Boston, Massachusetts, 02114
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Florida Hospital
Orlando, Florida, 32803
About this study
Official title: Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial
In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
Read the detailed description
Catheter ablation is a commonly performed strategy employed for the treatment of atrial fibrillation. However ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. When significant thermal injury to the esophagus occurs, two significant complications can occur: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the former is rate, it is an important complication since it can be fatal. The frequency of the latter complication is less well appreciated, but probably occurs in the range of 1:100 to 1:500. Currently luminal esophageal temperature monitoring is the most commonly employed modality to prevent such injury. However, there are limitations to its use, and atrio-esophageal fistulas have been reported even when using esophageal temperature monitoring. Esophageal deviation using either a TEE or EGD probe has been described in the literature, but the effectiveness and practicality of these techniques are suboptimal, and have therefore precluded their use in routine clinical practice. Recently, we have demonstrated that esophageal deviation is indeed possible using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) in patients undergoing AF ablation. In this randomized double-blind study, we will compare standard practice (i.e., use of luminal esophageal temperature monitoring) to esophageal deviation during AF ablation. We hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
- Conditions
- Esophageal Deviation, Atrial Fibrillation, Ablation
- Being tested
- esophageal deviation with IDE device
- Keywords
- Atrial Fibrillation ablation, Esophageal Deviation, AF
- 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 deviation with IDE deviceDevice
esophageal deviation during AF ablation
| Study group | Role | What they receive |
|---|---|---|
| esophageal deviation | Experimental | esophageal deviation with IDE device during AF ablation Receives: Device: esophageal deviation with IDE device |
| temperature monitoring | No intervention | luminal esophageal temperature monitoring, standard temperature monitoring alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Presence of Esophageal Injury
The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.
Measured: within 1 week of AF ablation procedure
Secondary outcomes (3)
Procedure Time
Procedure time and fluoroscopic imaging with barium contrast time
Measured: day 1, duration ofAF ablation procedure
Temperature
Extent of temperature rise on the temperature monitoring probe
Measured: during AF ablation procedure (intraoperative)
Swallowing Impairment Score
Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).
Measured: during AF ablation procedure (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Interim analysis: no statistically significant difference in the 2 study arms.
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 Esophageal DeviationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546168
- Sponsor's protocol ID
- GCO 11-0909
- Status last verified
- Jan 2018
- First submitted
- 13 Feb 2012
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01546168
- Acronym / sponsor ID
- GCO 11-0909
- Conditions
- Esophageal Deviation, Atrial Fibrillation, Ablation
- Keywords
- Atrial Fibrillation ablation, Esophageal Deviation, AF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis: no statistically significant difference in the 2 study arms.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
Detailed description
Catheter ablation is a commonly performed strategy employed for the treatment of atrial fibrillation. However ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. When significant thermal injury to the esophagus occurs, two significant complications can occur: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the former is rate, it is an important complication since it can be fatal. The frequency of the latter complication is less well appreciated, but probably occurs in the range of 1:100 to 1:500. Currently luminal esophageal temperature monitoring is the most commonly employed modality to prevent such injury. However, there are limitations to its use, and atrio-esophageal fistulas have been reported even when using esophageal temperature monitoring. Esophageal deviation using either a TEE or EGD probe has been described in the literature, but the effectiveness and practicality of these techniques are suboptimal, and have therefore precluded their use in routine clinical practice. Recently, we have demonstrated that esophageal deviation is indeed possible using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) in patients undergoing AF ablation. In this randomized double-blind study, we will compare standard practice (i.e., use of luminal esophageal temperature monitoring) to esophageal deviation during AF ablation. We hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esophageal deviation | Experimental | Device: esophageal deviation with IDE deviceesophageal deviation with IDE device during AF ablation |
| temperature monitoring | No intervention | –luminal esophageal temperature monitoring, standard temperature monitoring alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 - Age < 80 yr
- Documentation of atrial fibrillation (AF)
- Referred for a first ever ablation procedure for AF (prior ablation of right-sided Typical flutter, or "limited" left-sided of an accessory pathway are permitted)
- General anesthesia
- All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.
Key exclusion criteria (10 listed)
- Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
- INR > 4.0 at the time of the procedure
- H/o of severe esophageal ulcers, strictures, esophagitis or GERD
- H/o Esophageal Surgery
- Prior surgical or catheter ablation procedure for AF (except right atrial flutter ablation)
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 deviation with IDE deviceesophageal deviation during AF ablation | Device | esophageal deviation |
Primary outcome
Number of Participants With Presence of Esophageal Injury
Time frame: within 1 week of AF ablation procedure
The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.
3 secondary outcomes
Procedure Time
Time frame: day 1, duration ofAF ablation procedure
Temperature
Time frame: during AF ablation procedure (intraoperative)
Swallowing Impairment Score
Time frame: during AF ablation procedure (intraoperative)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophageal deviation with IDE device in people with Esophageal Deviation and Atrial Fibrillation, run by Vivek Reddy at 4 sites 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 23 Jan 2018). 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 of Participants With Presence of Esophageal Injury (time frame: within 1 week of AF 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 23 Jan 2018.