Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia (STRATUM VT)

This study has been terminated.
(low enrollment)
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01546207
First received: February 13, 2012
Last updated: March 24, 2014
Last verified: March 2014
Results First Received: August 20, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Ventricular Tachycardia
Catheter Ablation
Tachycardia, Ventricular
Intervention: Procedure: catheter-based ablation

  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
Patients were recruited from 12/2011 to 7/2013, at a medical clinic at MSSM.

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
Catheter-based Ablation catheter ablation - a medical procedure used to treat some types of arrhythmia

Participant Flow:   Overall Study
    Catheter-based Ablation  
STARTED     4  
COMPLETED     3  
NOT COMPLETED     1  
Death                 1  



  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
Catheter-based Ablation catheter ablation - a medical procedure used to treat some types of arrhythmia

Baseline Measures
    Catheter-based Ablation  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Mean ± Standard Deviation
  61.75  ± 7.18  
Gender  
[units: participants]
 
Female     0  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     4  
Czech Republic     0  
Canada     0  
Brazil     0  
Italy     0  



  Outcome Measures

1.  Primary:   Catheter Ablation   [ Time Frame: at time of catheter ablation procedure (intraoperative) ]

2.  Secondary:   ICD Interrogation   [ Time Frame: baseline and 6 months follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Procedural Safety   [ Time Frame: 1 week post-op ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Signal-Average ECG   [ Time Frame: baseline and post-op day one after procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Early termination due to poor enrollment. Data analysis not done - there is not enough data for meaningful analysis.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Vivek Y. Reddy
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-241-7114
e-mail: vivek.reddy@mountsinai.org


No publications provided


Responsible Party: Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01546207     History of Changes
Other Study ID Numbers: GCO 12-0045
Study First Received: February 13, 2012
Results First Received: August 20, 2013
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board