Atrial FibrillationNCT03261973
Esophageal Deviation in Atrial Fibrillation Ablation
A study testing DV8 in people with Atrial Fibrillation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- DV8
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 15 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A maximum of up to 54 patients will be enrolled in this prospective single-center single-arm study. Patients undergoing AF ablation (including paroxysmal and persistent AF) will be included in this study. Consistent with the current definitions, paroxysmal AF are episodes that will self-terminate in less than 24 hours. Persistent AF, is defined as ≥1 documented AF lasting >1week in duration or lasting less than 7 days but requiring electrical or pharmacological cardioversion to sinus rhythm.
- Age >18 - Age < 80 yr
- Documentation of atrial fibrillation (AF)
- 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 (international normalized ratio) > 4.0 at the time of the procedure
- History of (H/o) of severe esophageal ulcers, strictures, varices, bleeding, laceration or perforation, esophagitis
- Severe Gastroesophageal Reflux Disease (GERD)
- H/o esophageal surgery or any esophageal banding or cautery
- H/o chest radiation
Show all 11Show 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 (Human Chorionic Gonadotropin) test within 7 days prior to procedure
- Presence of left atrial thrombus
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. Thermal injury is very common and occurs in up to 40% of AF ablations per some studies. When significant thermal injury to the esophagus occurs, two significant complications can arise: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the occurrence of fistula is rare, it is a very important complication since it is often fatal. 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 continue to be a major problem in AF ablation even when using esophageal temperature monitoring. Esophageal deviation using either a Transesophageal echocardiogram (TEE) or Esophagogastroduodenoscopy (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, esophageal deviation using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) was tested in the randomized double-blind multicenter study "Deviating the Esophagus in Atrial Fibrillation Ablation (DEVIATE-AF)". In that study the standard practice (i.e., use of luminal esophageal temperature monitoring) was compared to esophageal deviation using off-the-shelf equipment. The results were very encouraging showing that esophageal deviation allowed for significant reductions in esophageal temperature and proportion of premature ablation terminations. Importantly, esophageal deviation allowed the isolation all PVs in the treatment group, which was not the case in the control group. One major limitation in the DEVIATE-AF trial was that off-the-shelf equipment tool was challenging to use. The aim of the Esophageal Deviation in Atrial Fibrillation Ablation study is to test the feasibility and safety of moving the esophagus using a specialized esophageal deviation tool (DV8, Manual Surgical Sciences, Minneapolis, MN).
- Conditions
- Atrial Fibrillation
- Being tested
- DV8
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DV8Device
DV8 esophageal deviation tool
| Study group | Role | What they receive |
|---|---|---|
| DV8 esophageal deviation tool | Other | This is a non-randomized one arm study. Receives: Device: DV8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus.
Measured: during Atrial Fibrillation (AF) ablation procedure (intraoperative)
Secondary outcomes (6)
Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.
Measured: during AF ablation procedure
Number of Participants Who Experienced Esophageal Laceration
Measured: within 1-90 days of the procedure
Number of Participants With PV Reconnection Assessed by Adenosine Infusion
Measured: during AF ablation procedure
Fluoroscopy Time Measured for the Whole Procedure
Measured: during AF ablation procedure
Procedure Duration Measured From the Initial Groin Stick to Catheter Removal
Measured: during the AF ablation procedure
Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery
Measured: during the AF ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start17 Nov 2017
- Primary completion15 Jun 2020
- Study completion15 Jun 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.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moussa C Mansour, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261973
- Sponsor's protocol ID
- 2017P001544
- Status last verified
- Jun 2021
- First submitted
- 21 Aug 2017
- Last updated
- 30 Jun 2021
- 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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Deviation in Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT03261973
- Acronym / sponsor ID
- 2017P001544
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 30 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. Thermal injury is very common and occurs in up to 40% of AF ablations per some studies. When significant thermal injury to the esophagus occurs, two significant complications can arise: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the occurrence of fistula is rare, it is a very important complication since it is often fatal. 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 continue to be a major problem in AF ablation even when using esophageal temperature monitoring. Esophageal deviation using either a Transesophageal echocardiogram (TEE) or Esophagogastroduodenoscopy (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, esophageal deviation using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) was tested in the randomized double-blind multicenter study "Deviating the Esophagus in Atrial Fibrillation Ablation (DEVIATE-AF)". In that study the standard practice (i.e., use of luminal esophageal temperature monitoring) was compared to esophageal deviation using off-the-shelf equipment. The results were very encouraging showing that esophageal deviation allowed for significant reductions in esophageal temperature and proportion of premature ablation terminations. Importantly, esophageal deviation allowed the isolation all PVs in the treatment group, which was not the case in the control group. One major limitation in the DEVIATE-AF trial was that off-the-shelf equipment tool was challenging to use. The aim of the Esophageal Deviation in Atrial Fibrillation Ablation study is to test the feasibility and safety of moving the esophagus using a specialized esophageal deviation tool (DV8, Manual Surgical Sciences, Minneapolis, MN).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DV8 esophageal deviation tool | Other | Device: DV8This is a non-randomized one arm study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A maximum of up to 54 patients will be enrolled in this prospective single-center single-arm study. Patients undergoing AF ablation (including paroxysmal and persistent AF) will be included in this study. Consistent with the current definitions, paroxysmal AF are episodes that will self-terminate in less than 24 hours. Persistent AF, is defined as ≥1 documented AF lasting >1week in duration or lasting less than 7 days but requiring electrical or pharmacological cardioversion to sinus rhythm.
- Age >18 - Age < 80 yr
- Documentation of atrial fibrillation (AF)
- 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 (11 listed)
- Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
- INR (international normalized ratio) > 4.0 at the time of the procedure
- History of (H/o) of severe esophageal ulcers, strictures, varices, bleeding, laceration or perforation, esophagitis
- Severe Gastroesophageal Reflux Disease (GERD)
- H/o esophageal surgery or any esophageal banding or cautery
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 |
|---|---|---|
| DV8DV8 esophageal deviation tool | Device | DV8 esophageal deviation tool |
Primary outcome
Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus.
Time frame: during Atrial Fibrillation (AF) ablation procedure (intraoperative)
6 secondary outcomes
Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.
Time frame: during AF ablation procedure
Number of Participants Who Experienced Esophageal Laceration
Time frame: within 1-90 days of the procedure
Number of Participants With PV Reconnection Assessed by Adenosine Infusion
Time frame: during AF ablation procedure
Fluoroscopy Time Measured for the Whole Procedure
Time frame: during AF ablation procedure
Procedure Duration Measured From the Initial Groin Stick to Catheter Removal
Time frame: during the AF ablation procedure
Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery
Time frame: during the AF ablation procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- 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 DV8 in people with Atrial Fibrillation, run by Massachusetts General Hospital 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 5 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 30 Jun 2021. 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 30 Jun 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 of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus. (time frame: during Atrial Fibrillation (AF) ablation procedure (intraoperative)). 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 30 Jun 2021.