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Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01426425
First received: August 29, 2011
Last updated: February 14, 2017
Last verified: February 2017
Results First Received: September 22, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: AtrioVentricular Nodal Reentrant Tachycardia
Supraventricular Tachycardia
Heart Disease
Intervention: Device: Freezor Xtra Cryoablation Catheter

  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
Thirty-seven (37) centers (8 in Canada, 29 in the US) confirmed participation in the study, with enrollments having occurred at 34 of those centers. First study enrollment occurred on 14-MAY-2012 and the last enrollment occurred on 25-FEB-2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Participants All subjects enrolled into the study.

Participant Flow:   Overall Study
    All Participants
STARTED   572 
EP Study   550 [1] 
Intent to Treat   399 [2] 
COMPLETED   397 [3] 
NOT COMPLETED   175 
Exited prior to EP study                22 
Inclusion/exclusion criteria not met                151 
Met inclusion/exclusion, not treated                2 
[1] EP study used to assess inclusion and exclusion criteria.
[2] Met all inclusion and no exclusion criteria.
[3] The pre-specified modified intent-to-treat analysis set was used for the primary objectives.



  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.
The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.

Reporting Groups
  Description
mITT Set The modified intent-to-treat (mITT) set.

Baseline Measures
   mITT Set 
Overall Participants Analyzed 
[Units: Participants]
 397 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.6  (13.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      279  70.3% 
Male      118  29.7% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Subject/physician chose not to provide information   10 
Not reportable per local laws or regulations   0 
American Indian or Alaska Native   1 
Asian   10 
Black or African American   16 
Hispanic or Latino   4 
Native Hawaiian or Pacific Islander   0 
White or Caucasian   353 
Two or more races   1 
Other race   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.   [ Time Frame: 6 months ]

2.  Primary:   Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.   [ Time Frame: 6 Months ]

3.  Secondary:   Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Jo Krueger, Senior Clinical Research Specialist
Organization: Medtronic
phone: 7635261551
e-mail: jo.krueger@medtronic.com



Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01426425     History of Changes
Other Study ID Numbers: ICY-AVNRT
Study First Received: August 29, 2011
Results First Received: September 22, 2016
Last Updated: February 14, 2017