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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01546207
Recruitment Status : Terminated (low enrollment)
First Posted : March 7, 2012
Results First Posted : April 24, 2014
Last Update Posted : July 27, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Ventricular Tachycardia
Catheter Ablation
Tachycardia, Ventricular
Intervention: Procedure: catheter-based ablation

  Participant Flow

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

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 
Overall Participants Analyzed 
[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.  

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

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.  


  Serious Adverse Events


  Other Adverse Events


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


  More Information

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



Responsible Party: Vivek Reddy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01546207     History of Changes
Other Study ID Numbers: GCO 12-0045
First Submitted: February 13, 2012
First Posted: March 7, 2012
Results First Submitted: August 20, 2013
Results First Posted: April 24, 2014
Last Update Posted: July 27, 2016