We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP) (Staged DEEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01661205
First Posted: August 9, 2012
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AtriCure, Inc.
Results First Submitted: February 7, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Intervention: Device: Ablation procedure staged catheter ablation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject treated on September 11, 2012. A total of 31 subjects consented from 6 sites (4 USA and 2 Europe). One subject was exited from the study prior to intervention and was re-consented. Only 30 unique subjects were enrolled in the study. Twenty-six subjects treated from 5 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five consented subjects were withdrew prior to treatment. Three did not meet the eligibility criteria, 1 subject was withdrawn by the investigator, and 1 subject withdrew consent.

Reporting Groups
  Description
AtriCure Bipolar System Combined With a Catheter Ablation

Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart

Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart


Participant Flow:   Overall Study
    AtriCure Bipolar System Combined With a Catheter Ablation
STARTED   26 
COMPLETED   24 
NOT COMPLETED   2 
Physician Decision                2 



  Baseline Characteristics
  Hide 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.
Number of Treated Subjects

Reporting Groups
  Description
AtriCure Bipolar System Combined With a Catheter Ablation

Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart

Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart


Baseline Measures
   AtriCure Bipolar System Combined With a Catheter Ablation 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  53.8% 
>=65 years      12  46.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.7  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  19.2% 
Male      21  80.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   3.8% 
White      24  92.3% 
More than one race      0   0.0% 
Unknown or Not Reported      1   3.8% 
Height 
[Units: Inches]
Mean (Standard Deviation)
 71.0  (3.9) 
Weight 
[Units: Lbs.]
Mean (Standard Deviation)
 220.9  (35.8) 
Body Mass Index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation)
 30.8  (3.9) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.   [ Time Frame: 30 days post-index procedure or hospital discharge ]

2.  Primary:   Number of Subjects With Absence of Atrial Fibrillation   [ Time Frame: 12 month follow-up ]

3.  Secondary:   Number Subjects With Serious Device or Procedure Related Adverse Event Rate   [ Time Frame: 12 month follow-up ]

4.  Secondary:   Number of Subjects With Acute Procedure Success   [ Time Frame: Day 0 ]

5.  Secondary:   Number of Subject Without Atrial Fibrillation   [ Time Frame: 6 and 12 month follow-up ]

6.  Secondary:   Number of Subjects With Reinterventions   [ Time Frame: 12 month follow-up ]

7.  Secondary:   Number of Subjects With Direct Current (DC) Cardioversion   [ Time Frame: 12 month follow-up ]

8.  Secondary:   Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores   [ Time Frame: 12 month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President, Clinical Operations
Organization: AtriCure, Inc.
phone: 513-755-4562
e-mail: SZink@AtriCure.com



Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT01661205     History of Changes
Other Study ID Numbers: CP2012-1
First Submitted: July 11, 2012
First Posted: August 9, 2012
Results First Submitted: February 7, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017