Anti-arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ventricular Tachycardia |
Procedure: MRI guided VT ablation Drug: Increased dose of amiodarone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Anti-arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia |
- Freedom from ventricular tachycardia documented by implantable defibrillator cardioverter 6 months post ablation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- inducible arrhythmia at the end of the procedure, [ Time Frame: During procedure ] [ Designated as safety issue: No ]
- Procedure time [ Time Frame: During procedure ] [ Designated as safety issue: No ]
- Comparison of endocardial voltage mapping to scar on delayed enhancement MRI images [ Time Frame: During procedure ] [ Designated as safety issue: No ]
- Complications of the procedure [ Time Frame: 30 days following procedure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 70 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Magnetic resonance imaging (MRI)-guided ablation of ventricular tachycardia.
|
Procedure: MRI guided VT ablation
Magnetic resonance imaging (MRI)-guided ablation of ventricular tachycardia (VT)
|
|
Active Comparator: 2
Anti-arrhythmic group.
|
Drug: Increased dose of amiodarone
Increase the dose of amiodarone according to the following scheme: current dose -> new dose 100 QD -> 200 QD; 200 QD -> 400 QD; 300 QD -> 600 QD; 400 QD -> 600 QD |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
- Current treatment with amiodarone
- Ischemic or non-ischemic cardiomyopathy
- Monomorphic ventricular tachycardia at any cycle length, with > 1 occurrence of the same cycle length and morphology, at least one episode needs to be of sufficient duration to result in a shock.
- No contraindication to up titration of meds or to VT RFA
Exclusion:
- Primary antiarrhythmic medication other than amiodarone
- Amiodarone at dose of 600 mg daily or higher
- Polymorphic VT as culprit rhythm
- History of metal exposure (welding)
- Pregnant women
- Recent myocardial infarction
- Planned coronary revascularization
- Implantable cardiac devices not previously tested for safety in the setting of MRI
- GFR < 30 ml/min
Contacts and Locations| Contact: Charles A Henrikson, MD | 410 955 2412 | chenriks@jhmi.edu |
| Contact: Saman Nazarian, MD | 410 614 2751 | snazarian@jhmi.edu |
More Information
No publications provided
| Responsible Party: | Charles Henrikson, MD - Cardiology/Medicine, Assistant Professor of Medicine, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00721032 History of Changes |
| Other Study ID Numbers: | NA_00011012 |
| Study First Received: | July 21, 2008 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
Ventricular tachycardia (VT) Implantable cardioverter-defibrillator (ICD) Ablation Cardiomyopathy Electrophysiology study |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone |
Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |
ClinicalTrials.gov processed this record on June 18, 2013