Ventricular Tachycardia (VT)PAUSE-SCDNCT02848781
Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
A study testing Implantable Cardioverter Defibrillator (ICD) and Catheter Ablation in people with Ventricular Tachycardia (VT), run by University of Arizona at 12 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT)
- What is being tested?
- Implantable Cardioverter Defibrillator (ICD) and Catheter Ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 30 Nov 2015to 29 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
China6 sites
Fuwai Cardiovascular Hospital
Beijing
Huaxi Hospital
Chengdu
Guangdong General Hospital
Guangzhou
Sir Run Run Shaw Hospital
Hangzhou
Nanjing First Affiliated Hospital
Nanjing
PLA Shenyang General Hospital
Shenyang
Japan3 sites
Dokkyo Medical University, Saitama Medical Center
Saitama
Kyorin University Hospital
Tokyo
Tsukuba University
Tsukuba
United States1 site
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: PAUSE-SCD: Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
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.
Read the 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.
- Conditions
- Ventricular Tachycardia (VT)
- Being tested
- Implantable Cardioverter Defibrillator (ICD), Catheter Ablation
- Keywords
- Sudden Cardiac Death, ICD Therapy, VT Ablation
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Catheter AblationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ICD with Ablation | Experimental | Patient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management. Receives: Device: Implantable Cardioverter Defibrillator (ICD); Procedure: Catheter Ablation |
| ICD Only | Active comparator | Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management. Receives: Device: Implantable Cardioverter Defibrillator (ICD) |
| 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. Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality
The primary endpoint is a composite.
Measured: 2 years
Secondary outcomes (3)
Freedom From Recurrent VT
Recurrent VT is defined as any appropriate ICD therapy (shock or ATP) or documented sustained monomorphic VT >30 seconds.
Measured: 2 years
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.
Measured: 2 years
Freedom From All-cause Mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start30 Nov 2015
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roderick Tung, MD, Study director, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848781
- Sponsor's protocol ID
- STUDY00000272
- Acronym
- PAUSE-SCD
- Status last verified
- Mar 2022
- First submitted
- 26 Jul 2016
- Last updated
- 14 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35507499Kheiri 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.
PubMed 31698933
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAUSE-SCD: Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
- ClinicalTrials.gov ID
- NCT02848781
- Acronym / sponsor ID
- PAUSE-SCD / STUDY00000272
- Conditions
- Ventricular Tachycardia (VT)
- Keywords
- Sudden Cardiac Death, ICD Therapy, VT Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Posted 14 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICD with Ablation | Experimental | Device: Implantable Cardioverter Defibrillator (ICD), Procedure: Catheter AblationPatient will receive an implantable cardioverter defibrillator (ICD) with catheter ablation and standard medical management. |
| ICD Only | Active comparator | Device: Implantable Cardioverter Defibrillator (ICD)Patient will receive an implantable cardioverter defibrillator (ICD) and standard medical management. |
| Ablation Only (Registry) | Active comparator | Procedure: Catheter AblationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ICD Only, ICD with Ablation |
| Catheter AblationCatheter 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. | Procedure or surgery | Ablation Only (Registry), ICD with Ablation |
Primary outcome
Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality
Time frame: 2 years
The primary endpoint is a composite.
3 secondary outcomes
Freedom From Recurrent VT
Time frame: 2 years
Freedom From Cardiovascular Rehospitalization
Time frame: 2 years
Freedom From All-cause Mortality
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35507499Tung 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.
- Derived from this study: PubMed 31698933Kheiri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roderick Tung, MD study director
University of Chicago
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Cardioverter Defibrillator (ICD) and Catheter Ablation in people with Ventricular Tachycardia (VT), run by University of Arizona at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China, Japan, United States, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848781, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.