Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (CALYPSO)
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ClinicalTrials.gov Identifier: NCT01576042 |
Recruitment Status :
Terminated
(Main objectives of the study were met; consensus among investigators that continuing the study would not add new information beyond that already learned.)
First Posted : April 12, 2012
Results First Posted : September 25, 2014
Last Update Posted : October 16, 2014
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Condition or disease | Intervention/treatment | Phase |
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Ventricular Tachycardia | Drug: amiodarone Drug: sotalol Device: Biosense Webster's NAVI-STAR Thermo-Cool | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (CALYPSO) PILOT TRIAL |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
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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
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Device: 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. |
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
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Drug: 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.
Other Name: Cordarone 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.
Other Names:
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- Number of Participants Completed Month 3 Follow-Up [ Time Frame: 3 months ]Records participants who completed Month 3 Follow-Up Visit
- Number of Participants Completed Month 6 Follow-Up [ Time Frame: 6 Months ]Records participants who completed Month 6 Follow-Up Visit
- Number of Participants Had at Least One of the Efficacy Outcome Measurement [ Time Frame: 6 Months ]Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)
- Cardiovascular Hospitalizations [ Time Frame: Baseline, 6 months ]Records participants hospitalized for VT during the study
- Number of Participants Remained on Randomized Treatment Assignment [ Time Frame: 6 month ]Records participants who only received study treatment as randomized during the entire study
- Number of Participants Switched to Other Arm [ Time Frame: 6 months ]Records participants who received study treatment as randomized and later switched to other treatment arm during the study
- Time to First Recurrent ICD Therapy for VT [ Time Frame: Baseline, 6 months ]Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.
- Number of Participants Received Treatment Assigned [ Time Frame: 6 months ]Records participants who received study randomized treatment during the study

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576042
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15237 |
Principal Investigator: | Sana M Al-Khatib, MD, MHS | Duke University | |
Principal Investigator: | William Stevenson, MD | Brigham and Women's Hospital |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01576042 |
Other Study ID Numbers: |
Pro00033180 Pro00036518 ( Other Identifier: Duke Site Protocol Number ) |
First Posted: | April 12, 2012 Key Record Dates |
Results First Posted: | September 25, 2014 |
Last Update Posted: | October 16, 2014 |
Last Verified: | September 2014 |
Ischemic heart disease Implantable Cardioverter Defibrillator Ventricular Tachycardia Patient with Implantable Cardioverter Defibrillator (ICD) |
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Cardiac Conduction System Disease Pathologic Processes Amiodarone Sotalol Anti-Arrhythmia Agents Vasodilator Agents Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Sodium Channel Blockers |
Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 CYP3A Inhibitors Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs Sympatholytics Autonomic Agents Peripheral Nervous System Agents |