Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator
NCT ID: NCT01576042
Last Updated: 2014-10-16
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
27 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-05-31
Study Completion Date
2014-05-31
Brief Summary
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The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic therapy at reducing all-cause mortality in patients with an implantable cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.
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Detailed Description
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This study will be conducted at up to 8 sites and will randomize 50 patients over 1 year to a strategy of catheter ablation (n=25) vs. state-of-the-art pharmacologic therapy (n=25). To be considered for enrollment in this pilot trial, patients must be at least 18 years of age and must have an ICD for a primary or secondary prevention indication, have ≥ 1 documented ICD shock or ≥ 3 ATP therapies for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy and be eligible for both catheter ablation and at least 1 antiarrhythmic medication. Patients will be followed at 3 and 6 months and their vital status will be determined via a phone call at 12 months. Data on the safety and efficacy of therapies used in the pilot study will be collected. Of particular interest are adverse events resulting from the catheter ablation procedure and major side effects from antiarrhythmic medications.
Conditions
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Ventricular Tachycardia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Catheter ablation
The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Group Type
OTHER
Biosense Webster's NAVI-STAR Thermo-Cool
Intervention Type
DEVICE
The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults.
Antiarrhythmic medication
The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
Group Type
OTHER
amiodarone
Intervention Type
DRUG
The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalol
Intervention Type
DRUG
The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
Interventions
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amiodarone
The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
Intervention Type
DRUG
sotalol
The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
Intervention Type
DRUG
Biosense Webster's NAVI-STAR Thermo-Cool
The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults.
Intervention Type
DEVICE
Other Intervention Names
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Cordarone
Betapace
Betapace AF
Sotalex
Sotacor
Eligibility Criteria
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Inclusion Criteria
* Have an ICD with or without cardiac resynchronization therapy (i.e. CRT-D) for a primary or secondary prevention indication
* Have ischemic heart disease defined as the presence of wall motion abnormalities and documented coronary artery disease (one ≥ 70% stenosis in ≥ 1 major coronary artery)
* Have ≥ 1 documented ICD shock or ≥ 3 ATP therapies within 6 months before randomization for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy. The VT has to be monomorphic and at a rate of ≤ 260 bpm.
* Be at least 18 years of age
* Be eligible for catheter ablation
* Have no history of intolerance or contraindication to at least 1 of the following antiarrhythmic medications: amiodarone, sotalol, and mexiletine.
Exclusion:
* Patients who in the opinion of the treating physician should not receive additional therapy
* More than 30 days of amiodarone treatment in the past 3 months unless the patient has been on ≤ 200 mgs of amiodarone daily for atrial arrhythmias or premature ventricular contractions (PVCs) and the patient is eligible for a higher dose of amiodarone
* Incessant VT that necessitates immediate treatment
* Reversible causes of VT including but not limited to ischemia, decompensated HF, and electrolyte disturbances
* The presence of a contraindication to catheter ablation of VT (including the presence of a mobile ventricular thrombus; an acute MI, coronary revascularization, or a stroke in the preceding 30 days; unstable angina or NYHA class IV HF; a mechanical valve; or inability to receive anticoagulation or antithrombotic therapy)
* Patients with non-ischemic cardiomyopathy
* Patients with hypertrophic obstructive, restrictive, or infiltrative cardiomyopathy
* Patients with acute myocarditis, congenital heart disease, valvular disease likely to require surgery in the next 1 year, and/or inoperable obstructive valvular disease
* Patients with a heart transplant or who are expected to undergo cardiac transplantation within 12 months
* Patients with a left ventricular assist device
* Patients who are already on antiarrhythmic drug therapy (other than beta-blockers) for VT (patients will not be excluded if they are receiving antiarrhythmic drug therapy for atrial arrhythmias or PVCs if they are eligible for additional drug therapy for VT).
* Heritable arrhythmias or increased risk for torsade de pointes with class III drugs
* End stage renal disease requiring dialysis
* Estimated life expectancy of \<1 year from a non-cardiac cause
* Women who are pregnant or who have childbearing potential and are not using a reliable method of contraception
* Inability to give informed consent
* Have ischemic heart disease defined as the presence of wall motion abnormalities and documented coronary artery disease (one ≥ 70% stenosis in ≥ 1 major coronary artery)
* Have ≥ 1 documented ICD shock or ≥ 3 ATP therapies within 6 months before randomization for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy. The VT has to be monomorphic and at a rate of ≤ 260 bpm.
* Be at least 18 years of age
* Be eligible for catheter ablation
* Have no history of intolerance or contraindication to at least 1 of the following antiarrhythmic medications: amiodarone, sotalol, and mexiletine.
Exclusion:
* Patients who in the opinion of the treating physician should not receive additional therapy
* More than 30 days of amiodarone treatment in the past 3 months unless the patient has been on ≤ 200 mgs of amiodarone daily for atrial arrhythmias or premature ventricular contractions (PVCs) and the patient is eligible for a higher dose of amiodarone
* Incessant VT that necessitates immediate treatment
* Reversible causes of VT including but not limited to ischemia, decompensated HF, and electrolyte disturbances
* The presence of a contraindication to catheter ablation of VT (including the presence of a mobile ventricular thrombus; an acute MI, coronary revascularization, or a stroke in the preceding 30 days; unstable angina or NYHA class IV HF; a mechanical valve; or inability to receive anticoagulation or antithrombotic therapy)
* Patients with non-ischemic cardiomyopathy
* Patients with hypertrophic obstructive, restrictive, or infiltrative cardiomyopathy
* Patients with acute myocarditis, congenital heart disease, valvular disease likely to require surgery in the next 1 year, and/or inoperable obstructive valvular disease
* Patients with a heart transplant or who are expected to undergo cardiac transplantation within 12 months
* Patients with a left ventricular assist device
* Patients who are already on antiarrhythmic drug therapy (other than beta-blockers) for VT (patients will not be excluded if they are receiving antiarrhythmic drug therapy for atrial arrhythmias or PVCs if they are eligible for additional drug therapy for VT).
* Heritable arrhythmias or increased risk for torsade de pointes with class III drugs
* End stage renal disease requiring dialysis
* Estimated life expectancy of \<1 year from a non-cardiac cause
* Women who are pregnant or who have childbearing potential and are not using a reliable method of contraception
* Inability to give informed consent
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Duke Clinical Research Institute
OTHER
Sponsor Role
collaborator
Duke University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sana M Al-Khatib, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Duke University
William Stevenson, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
Ohio State University Medical Center
Columbus, Ohio, United States
Site Status
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Site Status
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
References
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BACKGROUND
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BACKGROUND
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BACKGROUND
Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacretaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4.
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BACKGROUND
Other Identifiers
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Pro00036518
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00033180
Identifier Type: -
Identifier Source: org_study_id
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ENROLLING_BY_INVITATION
NA
Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease
NCT05203484
SUSPENDED
NA
Late Potentials and Ablation Index in Ventricular Tachycardia Ablation
NCT03437408
COMPLETED
NA
Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease
NCT04239144
RECRUITING
NA
Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia
NCT07017855
NOT_YET_RECRUITING
NA
In Silico Pace Mapping To Optimise Ventricular Tachycardia Ablation
NCT05500365
UNKNOWN
Cardiac RadiothErapy for VEntricular Tachycardia II
NCT06744530
RECRUITING
Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways
NCT04361006
COMPLETED
NA
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
NCT04065893
COMPLETED
Imaging With a Radio Tracer to Guide VT Ablations
NCT01250912
COMPLETED
NA
Non-invasive Ablation of Ventricular Tachycardia
NCT03601832
COMPLETED
NA
Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach
NCT02358746
UNKNOWN
NA
Ventricular Tachycardia Cohort
NCT07149701
NOT_YET_RECRUITING
Power Versus Temperature Controlled Ablation for Treatment of VT
NCT06028919
RECRUITING
NA
To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients
NCT01665755
COMPLETED
NA
Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)
NCT07240441
RECRUITING
NA
Comparision of PVC Ablation Techniques
NCT03086902
UNKNOWN
NA
Botulinum Toxin Injection to Prevent Ventricular Arrhythmias
NCT02003001
UNKNOWN
PHASE1
Stereotactic Non-invasive Ablation of Ventricular Tachycardia
NCT03819504
WITHDRAWN
NA