Esophageal Deviation in Atrial Fibrillation Ablation
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/17/2018 |
| Start Date: | November 17, 2017 |
| End Date: | August 30, 2019 |
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).
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).
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 > 4.0 at the time of the procedure
- H/o of severe esophageal ulcers, strictures, varices, bleeding, laceration or
perforation, esophagitis
- Severe 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 test within 7 days
prior to procedure
- Presence of left atrial thrombus
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-1697
Click here to add this to my saved trials
