Esophageal Deviation in Atrial Fibrillation Ablation

Not Applicable

Completed

Conditions: Atrial Fibrillation

Interventions: Device: DV8

Registration Number: NCT03261973

Lead Sponsor: Massachusetts General Hospital

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DV8 esophageal deviation tool	DV8	This is a non-randomized one arm study.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fluoroscopy Time Measured for the Whole Procedure	during AF ablation procedure
Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery	during the AF ablation procedure
Number of Participants Who Experienced Esophageal Laceration	within 1-90 days of the procedure
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 With PV Reconnection Assessed by Adenosine Infusion	during AF ablation procedure
Procedure Duration Measured From the Initial Groin Stick to Catheter Removal	during the AF ablation procedure