Esophageal Deviation in Atrial Fibrillation Ablation

NCT03261973 | Completed Results FDA Device

• 1 other identifier: 2017P001544
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (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.

  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.

  during AF ablation procedure

• Number of Participants Who Experienced Esophageal Laceration

  within 1-90 days of the procedure

• Number of Participants With PV Reconnection Assessed by Adenosine Infusion

  during AF ablation procedure

• Fluoroscopy Time Measured for the Whole Procedure

  during AF ablation procedure

• Procedure Duration Measured From the Initial Groin Stick to Catheter Removal

  during the AF ablation procedure

Study Arms (1)

DV8 esophageal deviation tool

OTHER

This is a non-randomized one arm study.

Device: DV8

Interventions

DV8 DEVICE

DV8 esophageal deviation tool

DV8 esophageal deviation tool

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Grace Ha
• Organization: Massachusetts General Hospital

gha2@mgh.harvard.edu

617-643-1697

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 25, 2017
• Study Start: November 17, 2017
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Locations

US (1)