Esophageal Deviation in Atrial Fibrillation Ablation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DV8
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
INCLUSION CRITERIA
- 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.
EXCLUSION CRITERIA
- 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
- 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DV8 esophageal deviation tool
Arm Description
This is a non-randomized one arm study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.
Number of Participants Who Experienced Esophageal Laceration
Number of Participants With PV Reconnection Assessed by Adenosine Infusion
Fluoroscopy Time Measured for the Whole Procedure
Procedure Duration Measured From the Initial Groin Stick to Catheter Removal
Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery
Full Information
NCT ID
NCT03261973
First Posted
August 21, 2017
Last Updated
June 28, 2021
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03261973
Brief Title
Esophageal Deviation in Atrial Fibrillation Ablation
Official Title
Esophageal Deviation in Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DV8 esophageal deviation tool
Arm Type
Other
Arm Description
This is a non-randomized one arm study.
Intervention Type
Device
Intervention Name(s)
DV8
Intervention Description
DV8 esophageal deviation tool
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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
Title
Number of Participants Who Experienced Esophageal Laceration
Time Frame
within 1-90 days of the procedure
Title
Number of Participants With PV Reconnection Assessed by Adenosine Infusion
Time Frame
during AF ablation procedure
Title
Fluoroscopy Time Measured for the Whole Procedure
Time Frame
during AF ablation procedure
Title
Procedure Duration Measured From the Initial Groin Stick to Catheter Removal
Time Frame
during the AF ablation procedure
Title
Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery
Time Frame
during the AF ablation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA
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.
EXCLUSION CRITERIA
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
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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Esophageal Deviation in Atrial Fibrillation Ablation
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