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Esophageal Deviation in Atrial Fibrillation Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03261973
Recruitment Status : Completed
First Posted : August 25, 2017
Results First Posted : June 30, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Moussa C Mansour, Massachusetts General Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: DV8 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Esophageal Deviation in Atrial Fibrillation Ablation
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
DV8 esophageal deviation tool
This is a non-randomized one arm study.
 Device: DV8
DV8 esophageal deviation tool


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Number of Participants Who Experienced Esophageal Laceration [ Time Frame: within 1-90 days of the procedure ]
  3. Number of Participants With PV Reconnection Assessed by Adenosine Infusion [ Time Frame: during AF ablation procedure ]
  4. Fluoroscopy Time Measured for the Whole Procedure [ Time Frame: during AF ablation procedure ]
  5. Procedure Duration Measured From the Initial Groin Stick to Catheter Removal [ Time Frame: during the AF ablation procedure ]
  6. Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery [ Time Frame: during the AF ablation procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261973


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Moussa C Mansour, Massachusetts General Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] July 18, 2019

More Information
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Responsible Party: Moussa C Mansour, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03261973    
Other Study ID Numbers: 2017P001544
First Posted: August 25, 2017    Key Record Dates
Results First Posted: June 30, 2021
Last Update Posted: June 30, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes