TerminatedNCT01576042CALYPSOUpdated Oct 16, 2014Results posted

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

An interventional study of amiodarone and sotalol in Ventricular Tachycardia, sponsored by Duke University. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-16.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Why this study was terminated

Main objectives of the study were met; consensus among investigators that continuing the study would not add new information beyond that already learned.

Phase: Not applicable
Study type: Interventional
Enrollment: 27
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Ventricular Tachycardia

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Keywords

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

In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's enrollment of 27 is below the median of 64 across 379 interventional studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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 criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 27 participants (actual)

Study arms

Other
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
Other
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 · Drug: sotalol

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.
Also known as: Cordarone
Drugsotalol
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.
Also known as: Betapace, Betapace AF, Sotalex, Sotacor
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.

What researchers measure

Primary outcomes

Number of Participants Completed Month 3 Follow-Up
Records participants who completed Month 3 Follow-Up Visit
Time frame: 3 months

Secondary outcomes

Number of Participants Completed Month 6 Follow-Up
Records participants who completed Month 6 Follow-Up Visit
Time frame: 6 Months
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
Cardiovascular Hospitalizations
Records participants hospitalized for VT during the study
Time frame: Baseline, 6 months
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
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
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
Number of Participants Received Treatment Assigned
Records participants who received study randomized treatment during the study
Time frame: 6 months

Results

Posted Sep 25, 2014

Participant flow

Participant flow — Overall Study
Milestone	Catheter Ablation	Antiarrhythmic Medication
Started	13	14
Switched to the other arm	5	1
Completed	11	14
Not completed	2	0
Withdrew: Physician decision	2	0

Outcome measures

PrimaryNumber of Participants Completed Month 3 Follow-Up

Records participants who completed Month 3 Follow-Up Visit

Time frame:: 3 months
Reported as:: Number · participants

Number of Participants Completed Month 3 Follow-Up
participants	Catheter Ablation	Antiarrhythmic Medication
Number of Participants Completed Month 3 Follow-Up	11	12

SecondaryNumber of Participants Completed Month 6 Follow-Up

Records participants who completed Month 6 Follow-Up Visit

Time frame:: 6 Months
Reported as:: Number · participants

Number of Participants Completed Month 6 Follow-Up
participants	Catheter Ablation	Antiarrhythmic Medication
Number of Participants Completed Month 6 Follow-Up	7	10

SecondaryNumber 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
Reported as:: Number · participants

Number of Participants Had at Least One of the Efficacy Outcome Measurement
participants	Catheter Ablation	Antiarrhythmic Medication
Number of Participants Had at Least One of the Efficacy Outcome Measurement	11	14

SecondaryCardiovascular Hospitalizations

Records participants hospitalized for VT during the study

Time frame:: Baseline, 6 months
Reported as:: Number · participants

Cardiovascular Hospitalizations
participants	Catheter Ablation	Antiarrhythmic Medication
Cardiovascular Hospitalizations	5	7

SecondaryNumber of Participants Remained on Randomized Treatment Assignment

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

Time frame:: 6 month
Reported as:: Number · participants

Number of Participants Remained on Randomized Treatment Assignment
participants	Catheter Ablation	Antiarrhythmic Medication
Number of Participants Remained on Randomized Treatment Assignment	6	13

SecondaryNumber 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
Reported as:: Number · participants

Number of Participants Switched to Other Arm
participants	Catheter Ablation	Antiarrhythmic Medication
Number of Participants Switched to Other Arm	5	1

SecondaryTime 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
Reported as:: Mean · Days

Time to First Recurrent ICD Therapy for VT
Days	Catheter Ablation	Antiarrhythmic Medication
Time to First Recurrent ICD Therapy for VT	70.1 ± 38.09	78.7 ± 62.08

SecondaryNumber of Participants Received Treatment Assigned

Records participants who received study randomized treatment during the study

Time frame:: 6 months
Reported as:: Number · participants

Number of Participants Received Treatment Assigned
participants	Catheter Ablation	Antiarrhythmic Medication
Number of Participants Received Treatment Assigned	11	14

Adverse events

Collected over Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Catheter Ablation	—	6/13 (46.2%)	7/13 (53.8%)
Antiarrhythmic Medication	—	7/14 (50%)	7/14 (50%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	Catheter Ablation	Antiarrhythmic Medication
Cardiac FailureCardiac disorders	5/13	1/14
Ventricular TachycardiaCardiac disorders	4/13	2/14
Device MalfunctionGeneral disorders	2/13	0/14
HematomaVascular disorders	1/13	0/14
Renal FailureRenal and urinary disorders	1/13	0/14
IleusGastrointestinal disorders	1/13	0/14
PneumoniaInfections and infestations	1/13	0/14
Aortic ThrombosisVascular disorders	0/13	1/14
Lung Neoplasm MalignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/13	1/14
Chest PainGeneral disorders	0/13	1/14

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	Catheter Ablation	Antiarrhythmic Medication
Ventricular TachycardiaCardiac disorders	3/13	2/14
Cardiac FailureCardiac disorders	2/13	1/14
HematomaVascular disorders	2/13	0/14
SyncopeNervous system disorders	0/13	2/14
HypotensionVascular disorders	1/13	0/14
IleusGastrointestinal disorders	1/13	0/14
NauseaGastrointestinal disorders	1/13	0/14
Device MalfunctionGeneral disorders	1/13	0/14
PneumoniaInfections and infestations	1/13	0/14
Renal FailureRenal and urinary disorders	1/13	0/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Catheter Ablation	Antiarrhythmic Medication	Total
<=18 years	0	0	0
Between 18 and 65 years	7	7	14
>=65 years	6	7	13

Sex: Female, Male
Sex: Female, Male(Participants)	Catheter Ablation	Antiarrhythmic Medication	Total
Female	0	2	2
Male	13	12	25

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Catheter Ablation	Antiarrhythmic Medication	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	4	6
White	11	10	21
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Catheter Ablation	Antiarrhythmic Medication	Total
United States	13	14	27

Study locations

5 sites

Johns Hopkins Hospital
Baltimore, Maryland 21287, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Ohio State University Medical Center
Columbus, Ohio 43210, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15237, United States

References and documents

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Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457. PubMed 18160685 ↗
Stevenson WG, Wilber DJ, Natale A, Jackman WM, Marchlinski FE, Talbert T, Gonzalez MD, Worley SJ, Daoud EG, Hwang C, Schuger C, Bump TE, Jazayeri M, Tomassoni GF, Kopelman HA, Soejima K, Nakagawa H; Multicenter Thermocool VT Ablation Trial Investigators. Irrigated radiofrequency catheter ablation guided by electroanatomic mapping for recurrent ventricular tachycardia after myocardial infarction: the multicenter thermocool ventricular tachycardia ablation trial. Circulation. 2008 Dec 16;118(25):2773-82. doi: 10.1161/CIRCULATIONAHA.108.788604. Epub 2008 Dec 8. PubMed 19064682 ↗
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. PubMed 20109864 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01576042
Lead sponsor: Duke University
Collaborators: Duke Clinical Research Institute
Responsible party: Sponsor
First posted: Apr 12, 2012
Start date: May 2012
Primary completion: May 2014
Completion: May 2014
Results posted: Sep 25, 2014
Last update: Oct 16, 2014

Study contacts

Sana M Al-Khatib, MD, MHS

principal investigator · Duke University

William Stevenson, MD

principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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