Trial Outcomes & Findings for Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (NCT NCT01576042)

NCT ID: NCT01576042

Last Updated: 2014-10-16

Results Overview

Records participants who completed Month 3 Follow-Up Visit

Recruitment status

TERMINATED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

3 months

Results posted on

2014-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	13	14
Overall Study Switched to the Other Arm	5	1
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Physician Decision	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Catheter Ablation n=13 Participants 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.	Antiarrhythmic Medication n=14 Participants 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 n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Records participants who completed Month 3 Follow-Up Visit

Outcome measures

Outcome measures
Measure	Catheter Ablation n=11 Participants 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.	Antiarrhythmic Medication n=14 Participants 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.
Number of Participants Completed Month 3 Follow-Up	11 participants	12 participants

SECONDARY outcome

Timeframe: 6 Months

Records participants who completed Month 6 Follow-Up Visit

Outcome measures

Outcome measures
Measure	Catheter Ablation n=11 Participants 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.	Antiarrhythmic Medication n=14 Participants 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.
Number of Participants Completed Month 6 Follow-Up	7 participants	10 participants

SECONDARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Catheter Ablation n=11 Participants 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.	Antiarrhythmic Medication n=14 Participants 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.
Number of Participants Had at Least One of the Efficacy Outcome Measurement	11 participants	14 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Records participants hospitalized for VT during the study

Outcome measures

Outcome measures
Measure	Catheter Ablation n=11 Participants 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.	Antiarrhythmic Medication n=14 Participants 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.
Cardiovascular Hospitalizations	5 participants	7 participants

SECONDARY outcome

Timeframe: 6 month

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

Outcome measures

Outcome measures
Measure	Catheter Ablation n=11 Participants 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.	Antiarrhythmic Medication n=14 Participants 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.
Number of Participants Remained on Randomized Treatment Assignment	6 participants	13 participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Catheter Ablation n=11 Participants 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.	Antiarrhythmic Medication n=14 Participants 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.
Number of Participants Switched to Other Arm	5 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

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

Outcome measures

Outcome measures
Measure	Catheter Ablation n=11 Participants 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.	Antiarrhythmic Medication n=14 Participants 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.
Time to First Recurrent ICD Therapy for VT	70.1 Days Standard Deviation 38.09	78.7 Days Standard Deviation 62.08

SECONDARY outcome

Timeframe: 6 months

Records participants who received study randomized treatment during the study

Outcome measures

Outcome measures
Measure	Catheter Ablation n=11 Participants 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.	Antiarrhythmic Medication n=14 Participants 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.
Number of Participants Received Treatment Assigned	11 participants	14 participants

Adverse Events

Catheter Ablation

Serious events: 6 serious events

Other events: 7 other events

Deaths: 0 deaths

Antiarrhythmic Medication

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Catheter Ablation n=13 participants at risk 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.	Antiarrhythmic Medication n=14 participants at risk 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.
Cardiac disorders Ventricular Tachycardia	30.8% 4/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	14.3% 2/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Vascular disorders Hematoma	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Cardiac disorders Cardiac Failure	38.5% 5/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Renal and urinary disorders Renal Failure	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Gastrointestinal disorders Ileus	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Infections and infestations Pneumonia	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
General disorders Device Malfunction	15.4% 2/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Vascular disorders Aortic Thrombosis	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
General disorders Chest Pain	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Cardiac disorders Myocardial Infarction	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Nervous system disorders Syncope	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Blood and lymphatic system disorders Anemia	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.

Other adverse events

Additional Information

Sana M. Al-Khatib, MD, MHS

Duke Clinical Research Institute

Phone: 919-668-8649

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Catheter Ablation n=13 participants at risk 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.	Antiarrhythmic Medication n=14 participants at risk 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.
Cardiac disorders Ventricular Tachycardia	23.1% 3/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	14.3% 2/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Cardiac disorders Cardiac Failure	15.4% 2/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Cardiac disorders Myocardial Infarction	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Vascular disorders Hematoma	15.4% 2/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Vascular disorders Aortic Thrombosis	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Vascular disorders Hypotension	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Gastrointestinal disorders Ileus	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Gastrointestinal disorders Nausea	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
General disorders Chest Pain	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
General disorders Device Malfunction	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Nervous system disorders Syncope	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	14.3% 2/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Blood and lymphatic system disorders Anemia	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Infections and infestations Pneumonia	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.00% 0/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	7.1% 1/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.
Renal and urinary disorders Renal Failure	7.7% 1/13 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.	0.00% 0/14 • Adverse events related to the procedure or the use of antiarrhythmic medications was collected thru 6 months 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.