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

Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (CALYPSO) PILOT TRIAL

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01576042
Acronym
CALYPSO
Enrollment
27
Registered
2012-04-12
Start date
2012-05-31
Completion date
2014-05-31
Last updated
2014-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Tachycardia

Keywords

Ischemic heart disease, Implantable Cardioverter Defibrillator, Ventricular Tachycardia, Patient with Implantable Cardioverter Defibrillator (ICD)

Brief summary

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.

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.

Interventions

DRUGamiodarone

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.

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.

DEVICEBiosense 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.

Sponsors

Duke Clinical Research Institute
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Completed Month 3 Follow-Up3 monthsRecords participants who completed Month 3 Follow-Up Visit

Secondary

MeasureTime frameDescription
Number of Participants Had at Least One of the Efficacy Outcome Measurement6 MonthsRecords participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)
Cardiovascular HospitalizationsBaseline, 6 monthsRecords participants hospitalized for VT during the study
Number of Participants Remained on Randomized Treatment Assignment6 monthRecords participants who only received study treatment as randomized during the entire study
Number of Participants Completed Month 6 Follow-Up6 MonthsRecords participants who completed Month 6 Follow-Up Visit
Time to First Recurrent ICD Therapy for VTBaseline, 6 monthsDays from the date of the first study treatment to the date of first ICD recurrent therapy for VT.
Number of Participants Received Treatment Assigned6 monthsRecords participants who received study randomized treatment during the study
Number of Participants Switched to Other Arm6 monthsRecords participants who received study treatment as randomized and later switched to other treatment arm during the study

Countries

United States

Participant flow

Participants by arm

ArmCount
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 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.
13
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 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. 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.
14
Total27

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision20

Baseline characteristics

CharacteristicCatheter AblationAntiarrhythmic MedicationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants7 Participants13 Participants
Age, Categorical
Between 18 and 65 years
7 Participants7 Participants14 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants4 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
11 Participants10 Participants21 Participants
Region of Enrollment
United States
13 participants14 participants27 participants
Sex: Female, Male
Female
0 Participants2 Participants2 Participants
Sex: Female, Male
Male
13 Participants12 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
7 / 137 / 14
serious
Total, serious adverse events
6 / 137 / 14

Outcome results

Primary

Number of Participants Completed Month 3 Follow-Up

Records participants who completed Month 3 Follow-Up Visit

Time frame: 3 months

ArmMeasureValue (NUMBER)
Catheter AblationNumber of Participants Completed Month 3 Follow-Up11 participants
Antiarrhythmic MedicationNumber of Participants Completed Month 3 Follow-Up12 participants
Secondary

Cardiovascular Hospitalizations

Records participants hospitalized for VT during the study

Time frame: Baseline, 6 months

ArmMeasureValue (NUMBER)
Catheter AblationCardiovascular Hospitalizations5 participants
Antiarrhythmic MedicationCardiovascular Hospitalizations7 participants
Secondary

Number of Participants Completed Month 6 Follow-Up

Records participants who completed Month 6 Follow-Up Visit

Time frame: 6 Months

ArmMeasureValue (NUMBER)
Catheter AblationNumber of Participants Completed Month 6 Follow-Up7 participants
Antiarrhythmic MedicationNumber of Participants Completed Month 6 Follow-Up10 participants
Secondary

Number of Participants Had at Least One of the Efficacy Outcome Measurement

Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)

Time frame: 6 Months

ArmMeasureValue (NUMBER)
Catheter AblationNumber of Participants Had at Least One of the Efficacy Outcome Measurement11 participants
Antiarrhythmic MedicationNumber of Participants Had at Least One of the Efficacy Outcome Measurement14 participants
Secondary

Number of Participants Received Treatment Assigned

Records participants who received study randomized treatment during the study

Time frame: 6 months

ArmMeasureValue (NUMBER)
Catheter AblationNumber of Participants Received Treatment Assigned11 participants
Antiarrhythmic MedicationNumber of Participants Received Treatment Assigned14 participants
Secondary

Number of Participants Remained on Randomized Treatment Assignment

Records participants who only received study treatment as randomized during the entire study

Time frame: 6 month

ArmMeasureValue (NUMBER)
Catheter AblationNumber of Participants Remained on Randomized Treatment Assignment6 participants
Antiarrhythmic MedicationNumber of Participants Remained on Randomized Treatment Assignment13 participants
Secondary

Number of Participants Switched to Other Arm

Records participants who received study treatment as randomized and later switched to other treatment arm during the study

Time frame: 6 months

ArmMeasureValue (NUMBER)
Catheter AblationNumber of Participants Switched to Other Arm5 participants
Antiarrhythmic MedicationNumber of Participants Switched to Other Arm1 participants
Secondary

Time to First Recurrent ICD Therapy for VT

Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.

Time frame: Baseline, 6 months

ArmMeasureValue (MEAN)Dispersion
Catheter AblationTime to First Recurrent ICD Therapy for VT70.1 DaysStandard Deviation 38.09
Antiarrhythmic MedicationTime to First Recurrent ICD Therapy for VT78.7 DaysStandard Deviation 62.08

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026