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Deviating the Esophagus in Atrial Fibrillation Ablation

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ClinicalTrials.gov Identifier: NCT01546168
Recruitment Status : Terminated (Interim analysis: no statistically significant difference in the 2 study arms.)
First Posted : March 7, 2012
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Esophageal Deviation
Atrial Fibrillation
Ablation
Intervention: Device: esophageal deviation with IDE device

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in November 2011, with enrollment beginning February 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
88 participants were consented, but 2 withdrew prior to randomization

Reporting Groups
  Description
Esophageal Deviation esophageal deviation with IDE device during AF ablation
Temperature Monitoring luminal esophageal standing temperature monitoring alone

Participant Flow:   Overall Study
    Esophageal Deviation   Temperature Monitoring
STARTED   55   33 
COMPLETED   51   33 
NOT COMPLETED   4   0 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                0 
ineligible after signing consent                2                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
17 roll-in patients and two pre-procedure withdrawals are removed from the analysis

Reporting Groups
  Description
Esophageal Deviation esophageal deviation with IDE device during AF ablation
Temperature Monitoring luminal esophageal standing temperature monitoring alone
Total Total of all reporting groups

Baseline Measures
   Esophageal Deviation   Temperature Monitoring   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   33   69 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.8  (8.3)   62.6  (8.6)   61.7  (8.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  33.3%      6  18.2%      18  26.1% 
Male      24  66.7%      27  81.8%      51  73.9% 
Persistent AF 
[Units: Participants]
Count of Participants
 16   15   31 
Paroxysmal AF 
[Units: Participants]
Count of Participants
 20   18   38 
CHADS Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.7  (0.8)   1  (0.9)   0.83  (0.9) 
[1] CHADS score for Stroke Risk Assessment in Atrial Fibrillation CHADS is a mnemonic for Congestive Heart Failure, Hypertension, Age over 75 years, Diabetes Mellitus, and Stroke or TIA history CHADS Score >2 (CVA risk >5% per year) CHADS Score 1 (CVA risk >4% per year) CHADS Score 0 (low risk)
History of GERD 
[Units: Participants]
Count of Participants
 5   4   9 


  Outcome Measures

1.  Primary:   Number of Participants With Presence of Esophageal Injury   [ Time Frame: within 1 week of AF ablation procedure ]

2.  Secondary:   Procedure Time   [ Time Frame: day 1, duration ofAF ablation procedure ]

3.  Secondary:   Temperature   [ Time Frame: during AF ablation procedure (intraoperative) ]

4.  Secondary:   Swallowing Impairment Score   [ Time Frame: during AF ablation procedure (intraoperative) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Vivek Y Reddy
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-241-7114
e-mail: vivek.reddy@mountsinai.org



Responsible Party: Vivek Reddy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01546168     History of Changes
Other Study ID Numbers: GCO 11-0909
First Submitted: February 13, 2012
First Posted: March 7, 2012
Results First Submitted: April 17, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018