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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD with Ablation | Experimental | Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management. |
|
| ICD Only | Active Comparator | Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management. |
|
| Ablation Only (Registry) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Cardioverter Defibrillator (ICD) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | The primary endpoint is a composite. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Recurrent VT | Recurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT >30 seconds. | 2 years |
| Freedom From Cardiovascular Rehospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Outcomes in Ablation Only Registry With Randomized Patients | 2 years |
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:
Patient has ejection fraction < 50% or right ventricular dysfunction
Patient has a cardiomyopathy with structural heart disease of any cause
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roderick Tung, MD | University of Chicago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Fuwai Cardiovascular Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35507499 | Derived | Tung R, Xue Y, Chen M, Jiang C, Shatz DY, Besser SA, Hu H, Chung FP, Nakahara S, Kim YH, Satomi K, Shen L, Liang E, Liao H, Gu K, Jiang R, Jiang J, Hori Y, Choi JI, Ueda A, Komatsu Y, Kazawa S, Soejima K, Chen SA, Nogami A, Yao Y; PAUSE-SCD Investigators. First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent With Defibrillator Implantation: The PAUSE-SCD Randomized Trial. Circulation. 2022 Jun 21;145(25):1839-1849. doi: 10.1161/CIRCULATIONAHA.122.060039. Epub 2022 May 4. | |
| 31698933 |
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Not Applicable - no wash out or run-in periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2021 |
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| Catheter Ablation | Procedure | 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. |
|
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.
| 2 years |
| Freedom From All-cause Mortality | 2 years |
| Beijing |
| China |
| Huaxi Hospital | Chengdu | China |
| Guangdong General Hospital | Guangzhou | China |
| Sir Run Run Shaw Hospital | Hangzhou | China |
| Nanjing First Affiliated Hospital | Nanjing | China |
| PLA Shenyang General Hospital | Shenyang | China |
| Dokkyo Medical University, Saitama Medical Center | Saitama | Japan |
| Kyorin University Hospital | Tokyo | Japan |
| Tsukuba University | Tsukuba | Japan |
| Korea University | Seoul | South Korea |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Derived |
| Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8. |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality | The primary endpoint is a composite. | Posted | Count of Participants | Participants | 2 years |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Freedom From Recurrent VT | Recurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT >30 seconds. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Freedom From All-cause Mortality | Posted | Count of Participants | Participants | 2 years |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Comparison of Outcomes in Ablation Only Registry With Randomized Patients | Posted | Number | participants | 2 years |
|
|
Subjects were followed for a mean of 2 years, and up to a maximum of 5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 5 | 60 | 20 | 60 | 19 | 60 |
| EG001 | 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. | 4 | 61 | 20 | 61 | 31 | 61 |
| EG002 | 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. | 3 | 47 | 15 | 47 | 15 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedure Complication | Cardiac disorders | Systematic Assessment |
| ||
| Rehospitalization | Cardiac disorders | Systematic Assessment |
| ||
| Mortality | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia, Palpitation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rodrick Tung, MD | College of Medicine - Phoenix | 602-521-3090 | rodricktung@arizona.edu |
| Jun 16, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2016 | Jun 16, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| China |
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| Japan |
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| Taiwan |
|
|
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. |
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| OG002 |
| 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. |
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