Trial Outcomes & Findings for Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia (NCT NCT01097330)

NCT ID: NCT01097330

Last Updated: 2020-01-29

Results Overview

Number of participants with a composite outcome of any of: 1. Appropriate Implantable Cardioverter Defibrillator (ICD) therapy \[Including antitachycardia pacing (ATP) and shocks\] 2. Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation 3. Sudden Cardiac Death

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: From 30 days following randomization until final follow-up visit
• Results posted on: 2020-01-29

Participant Flow

Participant milestones

Measure	Ablation Catheter based radiofrequency ablation for ischemic ventricular tachycardia Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization	Amiodarone amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study. Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Overall Study STARTED	7	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Measure	Ablation Catheter based radiofrequency ablation for ischemic ventricular tachycardia Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization	Amiodarone amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study. Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Overall Study Study terminated early	7	5

Baseline Characteristics

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

Baseline characteristics by cohort

Measure	Ablation n=7 Participants Catheter based radiofrequency ablation for ischemic ventricular tachycardia Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization	Amiodarone n=5 Participants amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study. Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study	Total n=12 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 9.7 • n=113 Participants	57 years STANDARD_DEVIATION 13.4 • n=163 Participants	61 years STANDARD_DEVIATION 11.3 • n=160 Participants
Sex: Female, Male Female	1 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants
Sex: Female, Male Male	6 Participants n=113 Participants	5 Participants n=163 Participants	11 Participants n=160 Participants
Region of Enrollment Canada	5 participants n=113 Participants	3 participants n=163 Participants	8 participants n=160 Participants
Region of Enrollment United States	1 participants n=113 Participants	0 participants n=163 Participants	1 participants n=160 Participants
Region of Enrollment China	1 participants n=113 Participants	2 participants n=163 Participants	3 participants n=160 Participants

PRIMARY outcome

Timeframe: From 30 days following randomization until final follow-up visit

Number of participants with a composite outcome of any of:

1. Appropriate Implantable Cardioverter Defibrillator (ICD) therapy [Including antitachycardia pacing (ATP) and shocks]

2. Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation

3. Sudden Cardiac Death

Outcome measures

Measure	Ablation n=7 Participants Catheter based radiofrequency ablation for ischemic ventricular tachycardia Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization	Amiodarone n=5 Participants amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study. Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death	1 participants	2 participants

SECONDARY outcome

Timeframe: from randomization until final follow-up

Number of Participants with (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks from ICD, or (c) Need for Concomitant use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic agents in either arm of the trial.

Outcome measures

Measure	Ablation n=7 Participants Catheter based radiofrequency ablation for ischemic ventricular tachycardia Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization	Amiodarone n=5 Participants amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study. Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial.	2 participants	0 participants

SECONDARY outcome

Timeframe: At 6 months follow-up

Population: Participants with data collected at 6 months

Quality of life score in each treatment arm using the EQ-5D Visual Analogue Scale (VAS) (euroqol.org). The EQ-5D VAS is a patient reported scale from 0 to 100 on which the patient rates how good or bad their health is today with 100 being the best health they can imagine and 0 being the worst health they can imagine.

Outcome measures

Measure	Ablation n=3 Participants Catheter based radiofrequency ablation for ischemic ventricular tachycardia Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization	Amiodarone n=3 Participants amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study. Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Quality of Life Score	59 score on a scale Interval 52.0 to 65.0	83 score on a scale Interval 70.0 to 95.0

Adverse Events

Ablation

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Amiodarone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ablation n=7 participants at risk Catheter based radiofrequency ablation for ischemic ventricular tachycardia Ablation: Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization	Amiodarone n=5 participants at risk amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study. Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Infections and infestations pneumonia	0.00% 0/7 • Follow-up period from date of randomization until final follow-up visit. Events were assessed at 1 month, 6 months and 12 months after randomization. Note that the study was terminated early for non-feasibility. 12 participants were enrolled, 9 completed 1 month of follow-up, 6 completed 6 months of follow-up and 1 completed 12 months of follow-up.	20.0% 1/5 • Number of events 1 • Follow-up period from date of randomization until final follow-up visit. Events were assessed at 1 month, 6 months and 12 months after randomization. Note that the study was terminated early for non-feasibility. 12 participants were enrolled, 9 completed 1 month of follow-up, 6 completed 6 months of follow-up and 1 completed 12 months of follow-up.
Renal and urinary disorders acute renal failure	0.00% 0/7 • Follow-up period from date of randomization until final follow-up visit. Events were assessed at 1 month, 6 months and 12 months after randomization. Note that the study was terminated early for non-feasibility. 12 participants were enrolled, 9 completed 1 month of follow-up, 6 completed 6 months of follow-up and 1 completed 12 months of follow-up.	20.0% 1/5 • Follow-up period from date of randomization until final follow-up visit. Events were assessed at 1 month, 6 months and 12 months after randomization. Note that the study was terminated early for non-feasibility. 12 participants were enrolled, 9 completed 1 month of follow-up, 6 completed 6 months of follow-up and 1 completed 12 months of follow-up.
Vascular disorders pseudo aneurysm	28.6% 2/7 • Follow-up period from date of randomization until final follow-up visit. Events were assessed at 1 month, 6 months and 12 months after randomization. Note that the study was terminated early for non-feasibility. 12 participants were enrolled, 9 completed 1 month of follow-up, 6 completed 6 months of follow-up and 1 completed 12 months of follow-up.	0.00% 0/5 • Follow-up period from date of randomization until final follow-up visit. Events were assessed at 1 month, 6 months and 12 months after randomization. Note that the study was terminated early for non-feasibility. 12 participants were enrolled, 9 completed 1 month of follow-up, 6 completed 6 months of follow-up and 1 completed 12 months of follow-up.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos Morillo

Population Health Research Institute

Phone: 905-527-4322

Email: Carlos.Morillo@phri.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place