Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AFreeze GmbH
ClinicalTrials.gov Identifier:
NCT01687036
First received: July 18, 2012
Last updated: November 25, 2013
Last verified: November 2013
Results First Received: July 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Intervention: Device: Cryoablation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: September 3,2012 - December 14, 2012 Locations: Medical University Innsbruck, General Hospital Linz

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
not applicable

Reporting Groups
  Description
Cryoablation

Cryoablation

Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (single treatment during visit 3).


Participant Flow:   Overall Study
    Cryoablation  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Cryoablation

Cryoablation

Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System


Baseline Measures
    Cryoablation  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  57.6  ± 7.6  
Gender  
[units: participants]
 
Female     4  
Male     6  
Region of Enrollment  
[units: participants]
 
Austria     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)   [ Time Frame: 3 months ]

2.  Primary:   Tolerability of Ablation Using the AFreeze Cryoablation System   [ Time Frame: Treatment Duration ]

3.  Secondary:   Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.   [ Time Frame: Treatment Duration ]

4.  Secondary:   Acute Efficacy of Catheter Ablation   [ Time Frame: Treatment Duration ]

5.  Secondary:   Clinical Efficacy of Catheter Ablation   [ Time Frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 ]

6.  Secondary:   Procedure Time   [ Time Frame: Average procedure time: 251 min. 06 sec. (range 126 – 320 min.) ]

7.  Secondary:   Fluoroscopy Time   [ Time Frame: Treatment Duration ]

8.  Secondary:   Cumulative Cryoablation Time   [ Time Frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 ]

9.  Secondary:   AE   [ Time Frame: First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Markus Stühlinger, MD
Organization: Medical University Innsbruck, Department of Internal Medicine III, Cardiology
phone: +43 512 504 ext 81 320
e-mail: markus.stuehlinger@uki.at


No publications provided


Responsible Party: AFreeze GmbH
ClinicalTrials.gov Identifier: NCT01687036     History of Changes
Other Study ID Numbers: CoolLoop First
Study First Received: July 18, 2012
Results First Received: July 19, 2013
Last Updated: November 25, 2013
Health Authority: Austria: Federal Office for Safety in Health Care