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

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01576042
• Collaborator: Duke Clinical Research Institute (Other)
• Enrollment: 27
• Locations: 5
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia	Drug: amiodarone; Drug: sotalol; Device: Biosense Webster's NAVI-STAR Thermo-Cool	N/A

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.

Study Design

• Study Type: Interventional
• 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 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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; 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.
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; 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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Completed Month 3 Follow-Up [3 months]

   Records participants who completed Month 3 Follow-Up Visit

Secondary Outcome Measures

1. Number of Participants Completed Month 6 Follow-Up [6 Months]

   Records participants who completed Month 6 Follow-Up Visit

2. Number of Participants Had at Least One of the Efficacy Outcome Measurement [6 Months]

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

3. Cardiovascular Hospitalizations [Baseline, 6 months]

   Records participants hospitalized for VT during the study

4. Number of Participants Remained on Randomized Treatment Assignment [6 month]

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

5. Number of Participants Switched to Other Arm [6 months]

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

6. Time to First Recurrent ICD Therapy for VT [Baseline, 6 months]

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

7. Number of Participants Received Treatment Assigned [6 months]

   Records participants who received study randomized treatment during the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	Ohio State University Medical Center	Columbus	Ohio	United States	43210
4	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
5	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

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01576042
• Other Study ID Numbers: Pro00033180; Pro00036518
• First Posted: Apr 12, 2012
• Last Update Posted: Oct 16, 2014
• Last Verified: Sep 1, 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; Amiodarone; Sotalol

Study Results

Participant Flow

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	13	14
Switched to the Other Arm	5	1
COMPLETED	11	14
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	13	14	27
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 53.8%	7 50%	14 51.9%
>=65 years	6 46.2%	7 50%	13 48.1%
Sex: Female, Male (Count of Participants)
Female	0 0%	2 14.3%	2 7.4%
Male	13 100%	12 85.7%	25 92.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 15.4%	4 28.6%	6 22.2%
White	11 84.6%	10 71.4%	21 77.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	13 100%	14 100%	27 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Completed Month 3 Follow-Up
Description	Records participants who completed Month 3 Follow-Up Visit
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Measure Participants	11	14
Number [participants]	11 84.6%	12 85.7%

2. Secondary Outcome

Title	Number of Participants Completed Month 6 Follow-Up
Description	Records participants who completed Month 6 Follow-Up Visit
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Measure Participants	11	14
Number [participants]	7 53.8%	10 71.4%

3. Secondary Outcome

Title	Number of Participants Had at Least One of the Efficacy Outcome Measurement
Description	Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Measure Participants	11	14
Number [participants]	11 84.6%	14 100%

4. Secondary Outcome

Title	Cardiovascular Hospitalizations
Description	Records participants hospitalized for VT during the study
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Measure Participants	11	14
Number [participants]	5 38.5%	7 50%

5. Secondary Outcome

Title	Number of Participants Remained on Randomized Treatment Assignment
Description	Records participants who only received study treatment as randomized during the entire study
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Measure Participants	11	14
Number [participants]	6 46.2%	13 92.9%

6. Secondary Outcome

Title	Number of Participants Switched to Other Arm
Description	Records participants who received study treatment as randomized and later switched to other treatment arm during the study
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Measure Participants	11	14
Number [participants]	5 38.5%	1 7.1%

7. Secondary Outcome

Title	Time to First Recurrent ICD Therapy for VT
Description	Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Measure Participants	11	14
Mean (Standard Deviation) [Days]	70.1 (38.09)	78.7 (62.08)

8. Secondary Outcome

Title	Number of Participants Received Treatment Assigned
Description	Records participants who received study randomized treatment during the study
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheter Ablation	Antiarrhythmic Medication
Arm/Group Description	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.	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.
Measure Participants	11	14
Number [participants]	11 84.6%	14 100%

Adverse Events

Time Frame	Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months
Adverse Event Reporting Description	All Serious and non serious adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months. All have been reported in the results.
Arm/Group Title	Catheter Ablation		Antiarrhythmic Medication
Arm/Group Description	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.		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.
All Cause Mortality
	Catheter Ablation		Antiarrhythmic Medication
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Catheter Ablation		Antiarrhythmic Medication
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/13 (46.2%)		7/14 (50%)
Blood and lymphatic system disorders
Anemia	0/13 (0%)		1/14 (7.1%)
Cardiac disorders
Ventricular Tachycardia	4/13 (30.8%)		2/14 (14.3%)
Cardiac Failure	5/13 (38.5%)		1/14 (7.1%)
Myocardial Infarction	0/13 (0%)		1/14 (7.1%)
Gastrointestinal disorders
Ileus	1/13 (7.7%)		0/14 (0%)
General disorders
Device Malfunction	2/13 (15.4%)		0/14 (0%)
Chest Pain	0/13 (0%)		1/14 (7.1%)
Infections and infestations
Pneumonia	1/13 (7.7%)		0/14 (0%)
Metabolism and nutrition disorders
Diabetes Mellitus	0/13 (0%)		1/14 (7.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant	0/13 (0%)		1/14 (7.1%)
Nervous system disorders
Syncope	0/13 (0%)		1/14 (7.1%)
Renal and urinary disorders
Renal Failure	1/13 (7.7%)		0/14 (0%)
Vascular disorders
Hematoma	1/13 (7.7%)		0/14 (0%)
Aortic Thrombosis	0/13 (0%)		1/14 (7.1%)
Other (Not Including Serious) Adverse Events
	Catheter Ablation		Antiarrhythmic Medication
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/13 (53.8%)		7/14 (50%)
Blood and lymphatic system disorders
Anemia	0/13 (0%)		1/14 (7.1%)
Cardiac disorders
Ventricular Tachycardia	3/13 (23.1%)		2/14 (14.3%)
Cardiac Failure	2/13 (15.4%)		1/14 (7.1%)
Myocardial Infarction	0/13 (0%)		1/14 (7.1%)
Gastrointestinal disorders
Ileus	1/13 (7.7%)		0/14 (0%)
Nausea	1/13 (7.7%)		0/14 (0%)
General disorders
Chest Pain	0/13 (0%)		1/14 (7.1%)
Device Malfunction	1/13 (7.7%)		0/14 (0%)
Infections and infestations
Pneumonia	1/13 (7.7%)		0/14 (0%)
Metabolism and nutrition disorders
Diabetes Mellitus	0/13 (0%)		1/14 (7.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant	0/13 (0%)		1/14 (7.1%)
Nervous system disorders
Syncope	0/13 (0%)		2/14 (14.3%)
Renal and urinary disorders
Renal Failure	1/13 (7.7%)		0/14 (0%)
Vascular disorders
Hematoma	2/13 (15.4%)		0/14 (0%)
Aortic Thrombosis	0/13 (0%)		1/14 (7.1%)
Hypotension	1/13 (7.7%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.