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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 21, 2008 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Freedom from ventricular tachycardia documented by implantable defibrillator cardioverter 6 months post ablation. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00721032 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Anti-Arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia | ||||||||
| Official Title ICMJE | Anti-Arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia | ||||||||
| Brief Summary | Ventricular tachycardia (VT) is a morbid arrhythmia responsible for many sudden deaths and ICD shocks. Despite much progress in the treatment of arrhythmia, VT remains a therapeutic challenge. Most patients with VT have an implantable cardioverter defibrillator (ICD) for secondary prevention of sudden cardiac death, however, an ICD merely treats VT, it does not prevent VT. In patients with recurrent VT and ICD shocks, two strategies are available to decrease the burden of VT. The first is antiarrhythmic drugs, and the second is VT ablation. The aim of this study is to compare the efficacy of antiarrhythmic drugs and VT ablation guided by MRI. VT can sometimes be suppressed with antiarrhythmic medications, however, these are often ineffective, and carry a high burden of side effects. Many forms of VT can be cured by selective destruction of critical electrical pathways with catheter ablation. A major limitation in the ablation of VT, however, is the time required to localize scar tissue and important pathways for targeting of lesions. Magnetic resonance imaging can now obtain reliable images of scar location within the ventricles. Recent advances in electroanatomical mapping systems allow operators to import pre-acquired images into the mapping system. The aim of this study is to examine the feasibility of importing historic MRI scar maps of the ventricles into the electroanatomical system and using such images to guide catheter ablation, as compared to antiarrhythmic drug suppression of VT. We suspect that MRI guidance will be especially useful in patients with "unstable" VT, i.e. VT that causes an abrupt drop in blood pressure, and thus cannot be maintained in the EP lab for mapping and entrainment purposes. Patients referred for VT ablation have ICDs. Through previously completed animal work (Circulation 2004; 110(5): 475-82) and a human trial (2006 Sep 19;114(12):1277-84) we have demonstrated the safety of MRI in the setting of pacemakers and implantable defibrillators using appropriate precautions. Through careful device programming and using MRI sequences with limited energy exposure (specific absorption rate < 2 W/kg) we will study the pre procedural myocardial anatomy of patients enrolled into this study. The primary endpoint will be lack of VT documented by implantable defibrillator (when present) interrogation or Holter monitoring 6 months post ablation. The secondary endpoints will be comparison of inducible arrhythmia at the end of the procedure, procedure time, comparison of endocardial voltage mapping to scar on delayed enhancement MRI images, and complications in each study arm. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Ventricular Tachycardia | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 70 | ||||||||
| Estimated Completion Date | August 2012 | ||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion:
Exclusion:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00721032 | ||||||||
| Responsible Party | Charles Henrikson, MD, Johns Hopkins University | ||||||||
| Study ID Numbers ICMJE | NA_00011012 | ||||||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | Johns Hopkins University | ||||||||
| Verification Date | July 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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