An interventional study of esophageal deviation with IDE device in Esophageal Deviation, Atrial Fibrillation and Ablation, sponsored by Vivek Reddy. Terminated at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Vivek Reddy · Not applicable, Interventional, and Prevention
In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
Catheter ablation is a commonly performed strategy employed for the treatment of atrial fibrillation. However ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. When significant thermal injury to the esophagus occurs, two significant complications can occur: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the former is rate, it is an important complication since it can be fatal. The frequency of the latter complication is less well appreciated, but probably occurs in the range of 1:100 to 1:500. 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 have been reported even when using esophageal temperature monitoring. Esophageal deviation using either a TEE or 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, we have demonstrated that esophageal deviation is indeed possible using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) in patients undergoing AF ablation. In this randomized double-blind study, we will compare standard practice (i.e., use of luminal esophageal temperature monitoring) to esophageal deviation during AF ablation. We hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 88 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Vivek Reddy is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
esophageal deviation with IDE device during AF ablation
Device: esophageal deviation with IDE device
luminal esophageal temperature monitoring, standard temperature monitoring alone
esophageal deviation during AF ablation
Number of Participants With Presence of Esophageal Injury
The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.
Time frame: within 1 week of AF ablation procedure
Procedure Time
Procedure time and fluoroscopic imaging with barium contrast time
Time frame: day 1, duration ofAF ablation procedure
Temperature
Extent of temperature rise on the temperature monitoring probe
Time frame: during AF ablation procedure (intraoperative)
Swallowing Impairment Score
Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).
Time frame: during AF ablation procedure (intraoperative)
Recruitment began in November 2011, with enrollment beginning February 2012
| Milestone | Esophageal Deviation | Temperature Monitoring |
|---|---|---|
| Started | 55 | 33 |
| Completed | 51 | 33 |
| Not completed | 4 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Ineligible after signing consent | 2 | 0 |
The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.
| Participants | Esophageal Deviation | Temperature Monitoring |
|---|---|---|
| Number of Participants With Presence of Esophageal Injury | 5 | 4 |
Procedure time and fluoroscopic imaging with barium contrast time
| minutes | Esophageal Deviation | Temperature Monitoring |
|---|---|---|
| Fluoroscopy time | 21.1 ± 9.9 | 20.9 ± 18.3 |
| Procedure duration | 3.39 ± 1.00 | 4.11 ± 1.07 |
Extent of temperature rise on the temperature monitoring probe
| Celsius | Esophageal Deviation | Temperature Monitoring |
|---|---|---|
| Temperature | 0.26 ± 0.2 | 1.1 ± 0.7 |
Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).
| units on a scale | Esophageal Deviation | Temperature Monitoring |
|---|---|---|
| Swallowing Impairment Score | 0.67 (0 to 4) | 0.27 (0 to 4) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Esophageal Deviation | 0/36 (0%) | 2/36 (5.6%) | 7/36 (19.4%) |
| Temperature Monitoring | 0/33 (0%) | 3/33 (9.1%) | 4/33 (12.1%) |
| Event | Esophageal Deviation | Temperature Monitoring |
|---|---|---|
| Pericardial EffusionCardiac disorders | 1/36 | 2/33 |
| Asthma ExacerbationRespiratory, thoracic and mediastinal disorders | 0/36 | 1/33 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/36 | 0/33 |
| Event | Esophageal Deviation | Temperature Monitoring |
|---|---|---|
| Atrial FlutterCardiac disorders | 3/36 | 0/33 |
| Nausea with abdominal painGastrointestinal disorders | 2/36 | 1/33 |
| Atrial FibrillationCardiac disorders | 0/36 | 1/33 |
| Acute BronchitisRespiratory, thoracic and mediastinal disorders | 0/36 | 1/33 |
| Urinary Tract InfectionRenal and urinary disorders | 0/36 | 1/33 |
| Groin HematomaRenal and urinary disorders | 1/36 | 0/33 |
| Venous ThrombophlebitisCardiac disorders | 1/36 | 0/33 |
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis
| Age, Continuous(years) | Esophageal Deviation | Temperature Monitoring | Total |
|---|---|---|---|
| Mean | 60.8 ± 8.3 | 62.6 ± 8.6 | 61.7 ± 8.4 |
| Sex: Female, Male(Participants) | Esophageal Deviation | Temperature Monitoring | Total |
|---|---|---|---|
| Female | 12 | 6 | 18 |
| Male | 24 | 27 | 51 |
| Persistent AF(Participants) | Esophageal Deviation | Temperature Monitoring | Total |
|---|---|---|---|
| Count of participants | 16 | 15 | 31 |
| Paroxysmal AF(Participants) | Esophageal Deviation | Temperature Monitoring | Total |
|---|---|---|---|
| Count of participants | 20 | 18 | 38 |
| CHADS Score(units on a scale) | Esophageal Deviation | Temperature Monitoring | Total |
|---|---|---|---|
| Mean | 0.7 ± 0.8 | 1 ± 0.9 | 0.83 ± 0.9 |
| History of GERD(Participants) | Esophageal Deviation | Temperature Monitoring | Total |
|---|---|---|---|
| Count of participants | 5 | 4 | 9 |
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Vivek Reddy