Trial Outcomes & Findings for Deviating the Esophagus in Atrial Fibrillation Ablation (NCT NCT01546168)
NCT ID: NCT01546168
Last Updated: 2018-01-23
Results Overview
The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
within 1 week of AF ablation procedure
Results posted on
2018-01-23
Participant Flow
Recruitment began in November 2011, with enrollment beginning February 2012
88 participants were consented, but 2 withdrew prior to randomization
Participant milestones
| Measure |
Esophageal Deviation
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
luminal esophageal standing temperature monitoring alone
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
33
|
|
Overall Study
COMPLETED
|
51
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Esophageal Deviation
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
luminal esophageal standing temperature monitoring alone
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
ineligible after signing consent
|
2
|
0
|
Baseline Characteristics
Deviating the Esophagus in Atrial Fibrillation Ablation
Baseline characteristics by cohort
| Measure |
Esophageal Deviation
n=36 Participants
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
n=33 Participants
luminal esophageal standing temperature monitoring alone
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Persistent AF
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Paroxysmal AF
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
CHADS Score
|
0.7 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
1 units on a scale
STANDARD_DEVIATION 0.9 • n=7 Participants
|
0.83 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
History of GERD
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 1 week of AF ablation procedurePopulation: 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.
Outcome measures
| Measure |
Esophageal Deviation
n=36 Participants
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
n=33 Participants
luminal esophageal standing temperature monitoring alone
|
|---|---|---|
|
Number of Participants With Presence of Esophageal Injury
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: day 1, duration ofAF ablation procedurePopulation: 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
Procedure time and fluoroscopic imaging with barium contrast time
Outcome measures
| Measure |
Esophageal Deviation
n=36 Participants
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
n=33 Participants
luminal esophageal standing temperature monitoring alone
|
|---|---|---|
|
Procedure Time
Fluoroscopy time
|
21.1 minutes
Standard Deviation 9.9
|
20.9 minutes
Standard Deviation 18.3
|
|
Procedure Time
Procedure duration
|
3.39 minutes
Standard Deviation 1.00
|
4.11 minutes
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: during AF ablation procedure (intraoperative)Population: 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
Extent of temperature rise on the temperature monitoring probe
Outcome measures
| Measure |
Esophageal Deviation
n=36 Participants
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
n=33 Participants
luminal esophageal standing temperature monitoring alone
|
|---|---|---|
|
Temperature
|
0.26 Celsius
Standard Deviation 0.2
|
1.1 Celsius
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: during AF ablation procedure (intraoperative)Population: 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).
Outcome measures
| Measure |
Esophageal Deviation
n=36 Participants
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
n=33 Participants
luminal esophageal standing temperature monitoring alone
|
|---|---|---|
|
Swallowing Impairment Score
|
0.67 units on a scale
Interval 0.0 to 4.0
|
0.27 units on a scale
Interval 0.0 to 4.0
|
Adverse Events
Esophageal Deviation
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Temperature Monitoring
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esophageal Deviation
n=36 participants at risk
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
n=33 participants at risk
luminal esophageal standing temperature monitoring alone
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.8%
1/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
0.00%
0/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
|
Cardiac disorders
Pericardial Effusion
|
2.8%
1/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
6.1%
2/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
0.00%
0/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
3.0%
1/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
Other adverse events
| Measure |
Esophageal Deviation
n=36 participants at risk
esophageal deviation with IDE device during AF ablation
|
Temperature Monitoring
n=33 participants at risk
luminal esophageal standing temperature monitoring alone
|
|---|---|---|
|
Cardiac disorders
Atrial Flutter
|
8.3%
3/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
0.00%
0/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
|
Renal and urinary disorders
Groin Hematoma
|
2.8%
1/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
0.00%
0/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
|
Gastrointestinal disorders
Nausea with abdominal pain
|
5.6%
2/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
3.0%
1/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
|
Cardiac disorders
Venous Thrombophlebitis
|
2.8%
1/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
0.00%
0/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
3.0%
1/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
0.00%
0/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
3.0%
1/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/36
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
3.0%
1/33
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
|
Additional Information
Dr. Vivek Y Reddy
Icahn School of Medicine at Mount Sinai
Phone: 212-241-7114
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place