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Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia (STOP-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: NCT00851279
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : August 24, 2015
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Stereotaxis

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ventricular Tachycardia
Intervention Device: Magnetic irrigated ablation catheter
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Magnetic Irrigated Ablation Catheter
Hide Arm/Group Description Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system
Period Title: Overall Study
Started 53
Completed 53
Not Completed 0
Arm/Group Title Magnetic Irrigated Ablation Catheter
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  37.7%
>=65 years
33
  62.3%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
67  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
4
   7.5%
Male
49
  92.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
United States 12
Czech Republic 32
Germany 9
Left Ventricular Ejection Fraction  
Mean (Inter-Quartile Range)
Unit of measure:  Percent
Number Analyzed 53 participants
31.5
(25 to 40)
History of cerebro-vascular accident (CVA)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
9
History of transient ischemic attack (TIA)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
3
History of diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
16
Pre-procedural arrhythmia treatment with beta-blockers  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
47
Pre-procedural arrhythmia treatment with amiodarone  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
34
ICD implanted prior to the ablation procedure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
38
1.Primary Outcome
Title Percentage of Participants Free From VT at 1 Year Post-Treatment
Hide Description In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.
Time Frame 1 Year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magnetic Irrigated Ablation Catheter
Hide Arm/Group Description:
Either the transseptal or transaortic approach was employed to gain access for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with RMN (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants free from VT
62
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Magnetic Irrigated Ablation Catheter
Hide Arm/Group Description

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

There were no adverse events associated with the procedure and within a 7 to 10 days post-doc window

All-Cause Mortality
Magnetic Irrigated Ablation Catheter
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Magnetic Irrigated Ablation Catheter
Affected / at Risk (%)
Total   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Magnetic Irrigated Ablation Catheter
Affected / at Risk (%)
Total   0/53 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Qun Sha, MD, Director of Clinical Trials
Organization: Stereotaxis Inc.
Phone: 314 678 6143
EMail: qun.sha@stereotaxis.com
Layout table for additonal information
Responsible Party: Stereotaxis
ClinicalTrials.gov Identifier: NCT00851279     History of Changes
Other Study ID Numbers: PM-CLIN-013
First Submitted: February 24, 2009
First Posted: February 25, 2009
Results First Submitted: December 2, 2013
Results First Posted: August 24, 2015
Last Update Posted: August 24, 2015