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

Ventricular Tachycardia Clinical Trial

— CALYPSO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01576042
• Other study ID #: Pro00033180
• Secondary ID: Pro00036518
• Status: Terminated
• Phase: N/A
• First received: April 3, 2012
• Last updated: October 6, 2014
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Clinical Research Institute

Country where clinical trial is conducted

United States, 

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Completed Month 3 Follow-Up	Records participants who completed Month 3 Follow-Up Visit	3 months	No
Secondary	Number of Participants Completed Month 6 Follow-Up	Records participants who completed Month 6 Follow-Up Visit	6 Months	No
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)	6 Months	Yes
Secondary	Cardiovascular Hospitalizations	Records participants hospitalized for VT during the study	Baseline, 6 months	Yes
Secondary	Number of Participants Remained on Randomized Treatment Assignment	Records participants who only received study treatment as randomized during the entire study	6 month	No
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	6 months	No
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.	Baseline, 6 months	Yes
Secondary	Number of Participants Received Treatment Assigned	Records participants who received study randomized treatment during the study	6 months	No