Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia (STOP-VT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stereotaxis
ClinicalTrials.gov Identifier:
NCT00851279
First received: February 24, 2009
Last updated: July 27, 2015
Last verified: July 2015
Results First Received: December 2, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ventricular Tachycardia
Intervention: Device: Magnetic irrigated ablation catheter

  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
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
Magnetic Irrigated Ablation Catheter Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system

Participant Flow:   Overall Study
    Magnetic Irrigated Ablation Catheter  
STARTED     53  
COMPLETED     53  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Magnetic Irrigated Ablation Catheter Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA).

Baseline Measures
    Magnetic Irrigated Ablation Catheter  
Number of Participants  
[units: participants]
  53  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     33  
Age  
[units: years]
Median (Standard Deviation)
  67  (7)  
Gender  
[units: participants]
 
Female     4  
Male     49  
Region of Enrollment  
[units: participants]
 
United States     12  
Czech Republic     32  
Germany     9  
Left Ventricular Ejection Fraction  
[units: percent]
Mean (Inter-Quartile Range)
  31.5   (25 to 40)  
History of cerebro-vascular accident (CVA)  
[units: participants]
  9  
History of transient ischemic attack (TIA)  
[units: participants]
  3  
History of diabetes  
[units: participants]
  16  
Pre-procedural arrhythmia treatment with beta-blockers  
[units: participants]
  47  
Pre-procedural arrhythmia treatment with amiodarone  
[units: participants]
  34  
ICD implanted prior to the ablation procedure  
[units: participants]
  38  



  Outcome Measures

1.  Primary:   Percentage of Participants Free From VT at 1 Year Post-Treatment   [ Time Frame: 1 Year 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 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 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: Dr Qun Sha, MD, Director of Clinical Trials
Organization: Stereotaxis Inc.
phone: 314 678 6143
e-mail: qun.sha@stereotaxis.com


No publications provided


Responsible Party: Stereotaxis
ClinicalTrials.gov Identifier: NCT00851279     History of Changes
Other Study ID Numbers: PM-CLIN-013
Study First Received: February 24, 2009
Results First Received: December 2, 2013
Last Updated: July 27, 2015
Health Authority: Czech Republic: Ethics Committee
United States: Institutional Review Board