CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) (PS-010)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT00621621
First received: February 13, 2008
Last updated: April 6, 2015
Last verified: April 2015
Results First Received: July 22, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tachycardia, Atrioventricular Nodal Reentry
Intervention: Device: Freezor® Cardiac Cryoablation Catheter CryoConsole System

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Focal Cryoablation Group

Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.

Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation

External Data Supporting the Study Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.

Participant Flow:   Overall Study
    Focal Cryoablation Group     External Data Supporting the Study  
STARTED     105 [1]   705  
COMPLETED     75 [2]   705  
NOT COMPLETED     30     0  
Subjects were exited at EP study                 30                 0  
[1] Date of Post- Approval Study protocol approval
[2] Treated with the experimental catheter



  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.
A total of 105 subjects gave actual consent in the study. Of the 105 consented 75 went on to have an ablation procedure performed. Data from 675 subjects were taken from published data that met inclusion criteria with publication search approved by the FDA.

Reporting Groups
  Description
Focal Cryoablation Group

Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.

Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation

Subjects Consented in the Study Not Ablated Actual Subjects that were consented in the study that did not meet inclusion criteria.
Subjects Collected From Published Data Published evidence about the safety and efficacy of using Medtronic’s Freezor® 4 mm CryoCatheter has been reported since the initiation of the CryoFACTS-PAS. The results reported in the literature provide the supplemental data in the same study population as in the PAS and are included to meet the study objectives, as agreed upon with the FDA.
Total Total of all reporting groups

Baseline Measures
    Focal Cryoablation Group     Subjects Consented in the Study Not Ablated     Subjects Collected From Published Data     Total  
Number of Participants  
[units: participants]
  75     30     675     780  
Age  
[units: years]
Mean (Standard Deviation)
  50.5  (17.8)     NA  (NA) [1]   NA  (NA) [1]   NA  (NA) [1]
Gender [2]
[units: participants]
       
Female     55     NA [1]   NA [1]   NA [3]
Male     20     NA [1]   NA [1]   NA [3]
Region of Enrollment  
[units: participants]
       
United States     75     30     NA [4]   NA [3]
[1] Data was not collected on subjects that were not ablated by the site.
[2] Baseline demographics were only collected for actual enrolled subjects (n=75) That were ablated. This data was not available for subjects enrolled from publicaton data (675).
[3] Total not calculated because data are not available (NA) in one or more arms.
[4] Regions were not collected from Publication data



  Outcome Measures
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1.  Primary:   Device or Procedure Related AV Block Persistent Through Discharge From Hospital.   [ Time Frame: After 250 subjects have been enrolled. ]

2.  Secondary:   AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.   [ Time Frame: After 250 subjects have been enrolled. ]


  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
Slow enrollment in the trial showed limited the amount of available data. Detailed subject data from the published literature was not available.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Adam Cline, MD, MSc.- Sr. Clinical Research Specialist
Organization: Medtronic- AF Solutions
phone: 763-526-9601
e-mail: adam.cline@medtronic.com


Publications:

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT00621621     History of Changes
Other Study ID Numbers: PS-010
Study First Received: February 13, 2008
Results First Received: July 22, 2014
Last Updated: April 6, 2015
Health Authority: United States: Institutional Review Board