Ventricular Tachycardia (VT)
Conditions
Keywords
Sudden Cardiac Death, ICD Therapy, VT Ablation
Brief summary
The current standard of care for ventricular tachycardia (VT) includes the use of medicine called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy. These treatments are used to terminate the irregular heartbeats and bring the heart back to a normal rhythm. Catheter ablation is a procedure used to eliminate (damage) the heart cells causing the arrhythmia. Patients eligible for this may benefit from an ablation procedure in addition to an ICD to treat their VT condition or risk of developing VT. This study aims to show that treating VT with catheter ablation, if performed preemptively at the time of ICD implantation, will reduce subsequent recurrent VT, ICD shocks, and lead to improved survival.
Detailed description
Subjects who meet inclusion/exclusion criteria will be entered into the randomized trial. Randomization will be 1:1 between control group and ablation group. Those randomized to the control group will receive ICD therapy and routine drug therapy (including antiarrhythmic drugs as indicated). Subjects randomized to the ablation group will receive ablation therapy plus ICD for ventricular tachycardia. Patients that refuse ICD therapy and undergo ablation only will be enrolled in a prospective registry. Follow-up will be performed prior to hospital discharge for incision check and device interrogation as is standard of care. In addition, routine device and clinical follow-up will be scheduled at 1, 3, 6, 12, 18, and 24 months. Electrocardiography (ECG) will be performed pre-implant and prior to hospital discharge. Echocardiography (TTE) will be performed pre-implant and at 12 and 24 months. Patients that refuse ICD implantation will not be randomized and will be approached for inclusion into a registry if they undergo catheter ablation without an ICD. Basic demographics and medical history will be collected from registry subjects upon enrollment. Registry subjects will receive follow-up for routine clinical care every 6 months to check on their overall status. 120 subjects will be randomized. An additional 60 subjects will enrolled into the registry. As of the time protocol revision C changes were made (07Nov2016), 33 subjects have been randomized. There has not been any preliminary or interim analysis of any data at this point. The study-sponsor has not had any access to any clinical follow-up for the patients enrolled to date.
Interventions
DEVICEImplantable Cardioverter Defibrillator (ICD)
An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
PROCEDURECatheter Ablation
Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is receiving a new implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy device (CRT-D) implant that has study required programing capabilities and is appropriate for remote monitoring. Patient who has received the ICD / CRT-D within 90 days of enrollment can also be enrolled. * Patient who has a high risk of ICD shock as shown by documented Monomorphic VT (MMVT) by one or more of the following: * Spontaneous MMVT * Inducible MMVT during electrophysiology study, * Inducible MMVT during noninvasive programmed stimulation study \*Inducible MMVT is defined as MMVT \> 30 seconds or requiring electrical termination (ATP or cardioversion) * Patient has ejection fraction \< 50% or right ventricular dysfunction * Patient has a cardiomyopathy with structural heart disease of any cause
Exclusion criteria
* Any history of debilitating stroke with neurologic deficit * ST-segment elevation myocardial infarction or previous cardiac surgery within 60 days prior to enrollment * Patient is pregnant or nursing * Patient has chronic New York Heart Association (NYHA) class IV heart failure * Patient has incessant VT necessitating immediate treatment * Patient has ventricular tachycardia/ventricular fibrillation thought to be from channelopathies * Limited life expectancy (less than one year) * Patient has current class IV angina * Recent coronary artery bypass graft or percutaneous coronary intervention (\< 45 days) * Patient is currently participating in another investigational drug or device study * Known presence of intracardiac thrombi * Prosthetic mitral or aortic valve or mitral or aortic valvular heart disease requiring immediate surgical intervention * Major contraindication to anticoagulation therapy or coagulation disorder * Left Ventricular Ejection Fraction \< 15% * Patient has had a previous ablation procedure for VT, excluding remote (\> 3 months) outflow tract tachycardia * Patient has glomerular filtration rate (GFR) \< 30 mL/min/1.73m2 * Patient has peripheral vascular disease that precludes left ventricular access * Patient is thought to have idiopathic outflow VT as only VT * Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD * Patient has reversible cause of VT * Patient does not meet criteria for ICD or CRT-D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | 2 years | The primary endpoint is a composite. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Recurrent VT | 2 years | Recurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT \>30 seconds. |
| Freedom From Cardiovascular Rehospitalization | 2 years | Cardiovascular rehospitalization is defined as a hospital admission after the randomized procedure for heart failure, procedure-associated complication, or arrhythmia-related causes during the follow-up period. |
| Freedom From All-cause Mortality | 2 years | — |
Other
| Measure | Time frame |
|---|---|
| Comparison of Outcomes in Ablation Only Registry With Randomized Patients | 2 years |
Countries
China, Japan, South Korea, Taiwan, United States
Participant flow
Pre-assignment details
Not Applicable - no wash out or run-in periods.
Participants by arm
| Arm | Count |
|---|---|
| ICD With Ablation Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm. | 60 |
| ICD Only Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management.
Implantable Cardioverter Defibrillator (ICD): An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat. | 61 |
| Ablation Only (Registry) The registry will enroll patients who refuse an implantable cardioverter defibrillator (ICD) and are thus not randomized. This arm will assess the efficacy of catheter ablation in the absence of background ICD therapy.
Catheter Ablation: Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm. | 47 |
| Total | 168 |
Baseline characteristics
| Characteristic | ICD With Ablation | ICD Only | Ablation Only (Registry) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 14 Participants | 7 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 47 Participants | 40 Participants | 131 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 60 Participants | 61 Participants | 47 Participants | 168 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 50 participants | 49 participants | 47 participants | 146 participants |
| Region of Enrollment Japan | 3 participants | 5 participants | 0 participants | 8 participants |
| Region of Enrollment South Korea | 2 participants | 1 participants | 0 participants | 3 participants |
| Region of Enrollment Taiwan | 5 participants | 6 participants | 0 participants | 11 participants |
| Sex: Female, Male Female | 16 Participants | 7 Participants | 7 Participants | 30 Participants |
| Sex: Female, Male Male | 44 Participants | 54 Participants | 40 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 60 | 4 / 61 | 3 / 47 |
| other Total, other adverse events | 19 / 60 | 31 / 61 | 15 / 47 |
| serious Total, serious adverse events | 20 / 60 | 20 / 61 | 15 / 47 |
Outcome results
Primary
Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality
The primary endpoint is a composite.
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ICD With Ablation | Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | Freedom from recurrent VT, cardiovascular rehospitalization, and all-cause mortality | 33 Participants |
| ICD With Ablation | Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | Recurrent VT, cardiovascular rehospitalization, and all-cause mortality | 27 Participants |
| ICD Only | Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | Freedom from recurrent VT, cardiovascular rehospitalization, and all-cause mortality | 25 Participants |
| ICD Only | Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | Recurrent VT, cardiovascular rehospitalization, and all-cause mortality | 36 Participants |
| Ablation Only (Registry) | Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | Freedom from recurrent VT, cardiovascular rehospitalization, and all-cause mortality | 28 Participants |
| Ablation Only (Registry) | Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | Recurrent VT, cardiovascular rehospitalization, and all-cause mortality | 19 Participants |
Secondary
Freedom From All-cause Mortality
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ICD With Ablation | Freedom From All-cause Mortality | Freedom from all-cause mortality | 55 Participants |
| ICD With Ablation | Freedom From All-cause Mortality | Experienced all-cause mortality | 5 Participants |
| ICD Only | Freedom From All-cause Mortality | Freedom from all-cause mortality | 57 Participants |
| ICD Only | Freedom From All-cause Mortality | Experienced all-cause mortality | 4 Participants |
| Ablation Only (Registry) | Freedom From All-cause Mortality | Freedom from all-cause mortality | 44 Participants |
| Ablation Only (Registry) | Freedom From All-cause Mortality | Experienced all-cause mortality | 3 Participants |
Secondary
Freedom From Cardiovascular Rehospitalization
Cardiovascular rehospitalization is defined as a hospital admission after the randomized procedure for heart failure, procedure-associated complication, or arrhythmia-related causes during the follow-up period.
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ICD With Ablation | Freedom From Cardiovascular Rehospitalization | Freedom from cardiovascular rehospitalization | 43 Participants |
| ICD With Ablation | Freedom From Cardiovascular Rehospitalization | Experienced cardiovascular rehospitalization | 17 Participants |
| ICD Only | Freedom From Cardiovascular Rehospitalization | Freedom from cardiovascular rehospitalization | 41 Participants |
| ICD Only | Freedom From Cardiovascular Rehospitalization | Experienced cardiovascular rehospitalization | 20 Participants |
| Ablation Only (Registry) | Freedom From Cardiovascular Rehospitalization | Freedom from cardiovascular rehospitalization | 35 Participants |
| Ablation Only (Registry) | Freedom From Cardiovascular Rehospitalization | Experienced cardiovascular rehospitalization | 12 Participants |
Secondary
Freedom From Recurrent VT
Recurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT \>30 seconds.
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ICD With Ablation | Freedom From Recurrent VT | Freedom from recurrent VT | 41 Participants |
| ICD With Ablation | Freedom From Recurrent VT | Experienced recurrent VT | 19 Participants |
| ICD Only | Freedom From Recurrent VT | Freedom from recurrent VT | 30 Participants |
| ICD Only | Freedom From Recurrent VT | Experienced recurrent VT | 31 Participants |
| Ablation Only (Registry) | Freedom From Recurrent VT | Freedom from recurrent VT | 32 Participants |
| Ablation Only (Registry) | Freedom From Recurrent VT | Experienced recurrent VT | 15 Participants |
Other Pre-specified
Comparison of Outcomes in Ablation Only Registry With Randomized Patients
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ICD With Ablation | Comparison of Outcomes in Ablation Only Registry With Randomized Patients | Recurrence of VT | 50 participants |
| ICD With Ablation | Comparison of Outcomes in Ablation Only Registry With Randomized Patients | Cardiovascular Rehospitalization | 37 participants |
| ICD With Ablation | Comparison of Outcomes in Ablation Only Registry With Randomized Patients | All-Cause Mortality | 9 participants |
| ICD Only | Comparison of Outcomes in Ablation Only Registry With Randomized Patients | All-Cause Mortality | 3 participants |
| ICD Only | Comparison of Outcomes in Ablation Only Registry With Randomized Patients | Recurrence of VT | 15 participants |
| ICD Only | Comparison of Outcomes in Ablation Only Registry With Randomized Patients | Cardiovascular Rehospitalization | 12 participants |