An interventional study of DV8 in Atrial Fibrillation, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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).
EXCLUSION CRITERIA
This is a non-randomized one arm study.
Device: DV8
DV8 esophageal deviation tool
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)
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
Number of Participants Who Experienced Esophageal Laceration
Time frame: within 1-90 days of the procedure
Number of Participants With PV Reconnection Assessed by Adenosine Infusion
Time frame: during AF ablation procedure
Fluoroscopy Time Measured for the Whole Procedure
Time frame: during AF ablation procedure
Procedure Duration Measured From the Initial Groin Stick to Catheter Removal
Time frame: during the AF ablation procedure
Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery
Time frame: during the AF ablation procedure
| Milestone | DV8 Esophageal Deviation Tool |
|---|---|
| Started | 47 |
| Completed | 43 |
| Not completed | 4 |
| Participants | DV8 Esophageal Deviation Tool |
|---|---|
| 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. | 42 |
| Participants | DV8 Esophageal Deviation Tool |
|---|---|
| Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs. | 9 |
| Participants | DV8 Esophageal Deviation Tool |
|---|---|
| Number of Participants Who Experienced Esophageal Laceration | 0 |
| Participants | DV8 Esophageal Deviation Tool |
|---|---|
| Number of Participants With PV Reconnection Assessed by Adenosine Infusion | 10 |
| minutes | DV8 Esophageal Deviation Tool |
|---|---|
| Fluoroscopy Time Measured for the Whole Procedure | 23.8 ± 8.1 |
| minutes | DV8 Esophageal Deviation Tool |
|---|---|
| Procedure Duration Measured From the Initial Groin Stick to Catheter Removal | 212 ± 32 |
| minutes | DV8 Esophageal Deviation Tool |
|---|---|
| Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery | 53.2 ± 16.2 |
Collected over The duration of the study was 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DV8 Esophageal Deviation Tool | 0/43 (0%) | 0/43 (0%) | 2/43 (4.7%) |
| Event | DV8 Esophageal Deviation Tool |
|---|---|
| GastroparesisGastrointestinal disorders | 1/43 |
| PericarditisCardiac disorders | 1/43 |
| Age, Continuous(years) | DV8 Esophageal Deviation Tool |
|---|---|
| Mean | 61.9 ± 9.1 |
| Sex: Female, Male(Participants) | DV8 Esophageal Deviation Tool |
|---|---|
| Female | 12 |
| Male | 31 |
| Race and Ethnicity Not Collected(Participants) | DV8 Esophageal Deviation Tool |
|---|
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital