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Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (CALYPSO)

This study has been terminated.
(Main objectives of the study were met; consensus among investigators that continuing the study would not add new information beyond that already learned.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01576042
First Posted: April 12, 2012
Last Update Posted: October 16, 2014
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.
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Ventricular Tachycardia Drug: amiodarone Drug: sotalol Device: Biosense Webster's NAVI-STAR Thermo-Cool

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of Participants Completed Month 3 Follow-Up [ Time Frame: 3 months ]
    Records participants who completed Month 3 Follow-Up Visit


Secondary Outcome Measures:
  • 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


Enrollment: 27
Study Start Date: May 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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:
  • Betapace
  • Betapace AF
  • Sotalex
  • Sotacor

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Duke University
Duke Clinical Research Institute
Investigators
Principal Investigator: Sana M Al-Khatib, MD, MHS Duke University
Principal Investigator: William Stevenson, MD Brigham and Women's Hospital
  More Information

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Hammill SC, Stevenson LW, Kadish AH, Kremers MS, Heidenreich P, Lindsay BD, Mirro MJ, Radford MJ, Wang Y, Lang CM, Harder JC, Brindis RG. Review of the registry's first year, data collected, and future plans. Heart Rhythm. 2007 Sep;4(9):1260-3. Epub 2007 Jul 25.
Hammill SC, Kremers MS, Stevenson LW, Kadish AH, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, Wang Y, Curtis JP, Lang CM, Harder JC, Brindis RG. Review of the Registry's second year, data collected, and plans to add lead and pediatric ICD procedures. Heart Rhythm. 2008 Sep;5(9):1359-63. doi: 10.1016/j.hrthm.2008.07.015. Epub 2008 Jul 22.
Hammill SC, Kremers MS, Kadish AH, Stevenson LW, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, McKay C, Wang Y, Lang CM, Pontzer K, Rumsfeld J, Phurrough SE, Curtis JP, Brindis RG. Review of the ICD Registry's third year, expansion to include lead data and pediatric ICD procedures, and role for measuring performance. Heart Rhythm. 2009 Sep;6(9):1397-401. doi: 10.1016/j.hrthm.2009.07.015. Epub 2009 Jul 16.
Hammill SC, Kremers MS, Stevenson LW, Heidenreich PA, Lang CM, Curtis JP, Wang Y, Berul CI, Kadish AH, Al-Khatib SM, Pina IL, Walsh MN, Mirro MJ, Lindsay BD, Reynolds MR, Pontzer K, Blum L, Masoudi F, Rumsfeld J, Brindis RG. Review of the registry's fourth year, incorporating lead data and pediatric ICD procedures, and use as a national performance measure. Heart Rhythm. 2010 Sep;7(9):1340-5. doi: 10.1016/j.hrthm.2010.07.015. Epub 2010 Jul 18. Review.
Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098.
Sweeney MO, Sherfesee L, DeGroot PJ, Wathen MS, Wilkoff BL. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Mar;7(3):353-60. doi: 10.1016/j.hrthm.2009.11.027. Epub 2009 Dec 2.
Noyes K, Corona E, Veazie P, Dick AW, Zhao H, Moss AJ. Examination of the effect of implantable cardioverter-defibrillators on health-related quality of life: based on results from the Multicenter Automatic Defibrillator Trial-II. Am J Cardiovasc Drugs. 2009;9(6):393-400. doi: 10.2165/11317980-000000000-00000.
Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med. 1989 Aug 10;321(6):406-12.
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Cardiac Arrhythmia Suppression Trial II Investigators. Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med. 1992 Jul 23;327(4):227-33.
Waldo AL, Camm AJ, deRuyter H, Friedman PL, MacNeil DJ, Pauls JF, Pitt B, Pratt CM, Schwartz PJ, Veltri EP. Effect of d-sotalol on mortality in patients with left ventricular dysfunction after recent and remote myocardial infarction. The SWORD Investigators. Survival With Oral d-Sotalol. Lancet. 1996 Jul 6;348(9019):7-12. Erratum in: Lancet 1996 Aug 10;348(9024):416.
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01576042     History of Changes
Other Study ID Numbers: Pro00033180
Pro00036518 ( Other Identifier: Duke Site Protocol Number )
First Submitted: April 3, 2012
First Posted: April 12, 2012
Results First Submitted: September 18, 2014
Results First Posted: September 25, 2014
Last Update Posted: October 16, 2014
Last Verified: September 2014

Keywords provided by Duke University:
Ischemic heart disease
Implantable Cardioverter Defibrillator
Ventricular Tachycardia
Patient with Implantable Cardioverter Defibrillator (ICD)

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Sotalol
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


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