NCT03261973

Esophageal Deviation in Atrial Fibrillation Ablation

Completed NA Results posted Last updated 30 June 2021

What this trial tests

NA trial testing DV8 in Atrial Fibrillation in 47 participants. Completed in 15 June 2020.

Timeline

17 November 2017

Primary endpoint
15 June 2020

15 June 2020

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	47
Start date	17 November 2017
Primary completion	15 June 2020
Estimated completion	15 June 2020
Sites	1 location across United States

Drugs / interventions tested

• DV8

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · during Atrial Fibrillation (AF) ablation procedure (intraoperative)

Group	Value	95% CI
DV8 Esophageal Deviation Tool	42

Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs. Secondary · during AF ablation procedure

Group	Value	95% CI
DV8 Esophageal Deviation Tool	9

Number of Participants Who Experienced Esophageal Laceration Secondary · within 1-90 days of the procedure

Group	Value	95% CI
DV8 Esophageal Deviation Tool	0

Number of Participants With PV Reconnection Assessed by Adenosine Infusion Secondary · during AF ablation procedure

Group	Value	95% CI
DV8 Esophageal Deviation Tool	10

Fluoroscopy Time Measured for the Whole Procedure Secondary · during AF ablation procedure

Group	Value	95% CI
DV8 Esophageal Deviation Tool	23.8	± 8.1

Procedure Duration Measured From the Initial Groin Stick to Catheter Removal Secondary · during the AF ablation procedure

Group	Value	95% CI
DV8 Esophageal Deviation Tool	212	± 32

Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery Secondary · during the AF ablation procedure

Group	Value	95% CI
DV8 Esophageal Deviation Tool	53.2	± 16.2

Adverse events — posted to ClinicalTrials.gov

Time frame: The duration of the study was 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DV8 Esophageal Deviation Tool

Serious: 0/43 (0%)

Deaths: 0/43

Other adverse events (2 terms — click to expand)

Reaction	System	DV8 Esophageal Deviation T…
Gastroparesis	Gastrointestinal disorders	—
Pericarditis	Cardiac disorders	—

Data from ClinicalTrials.gov NCT03261973 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.