Defibrillators, ImplantablePhase 3CEASE-VTNCT01097330
Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
A Phase 3 study testing Ablation and Amiodarone in people with Defibrillators, Implantable and Tachycardia, Ventricular, run by Population Health Research Institute at 11 sites in 3 countries.
Trial summary
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). Read more about this study
- Who is it for?
- Ages 19 to 84 years
- Conditions the study is for
- Defibrillators, Implantable, Tachycardia, Ventricular
- What is being tested?
- Ablation and Amiodarone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Aug 2010to Mar 2012
- Phase
- Phase 3
- 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 19 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria - Patients must meet all of the following criteria:
- > 18 and < 85 years of age
- ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
- Coronary artery disease (CAD) with prior myocardial infarction (MI)
- ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy [antitachycardia pacing (ATP) \& shocks].
Exclusion Criteria - Patients should not have any of the following criteria:
- Contraindication or allergy to contrast media, routine procedural medications or catheter materials
- Contraindication to an interventional procedure
- Current or previous (within 3 months) amiodarone therapy
- Atrial Fibrillation requiring antiarrhythmic drug therapy
- Contraindication to amiodarone therapy
- New York Heart Association (NYHA) functional class IV
- Myocardial infarction within the past 60 days
- Stroke within the past 90 days
- Unstable angina
- Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome
- Patients with active ischemia that are eligible for revascularization
- Life expectancy less than 6 months
- Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
- Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
- Current enrollment in another investigational drug or device study.
- Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period.
- Absolute contra-indication to the use of heparin and or warfarin.
- Documented intra-atrial thrombus, ventricular thrombus (< 6 months after detection of thrombus), tumor, or another abnormality which precludes catheter introduction.
- Females of childbearing potential who are not practicing protocol acceptable method of birth control.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States5 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Canada5 sites
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
McGill University Health Center
Montreal, Quebec, H3G 1A4
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Institut Universitaire de Cardiologie et Pneumologie de Québec
Québec, G1V 4G5
About this study
Official title: Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia: A Multi-center Randomized Trial
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This study is designed to determine the best way to manage patients who have an ICD and who continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and 2) Medication.
An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area and threading it into the heart. After the doctor has located the affected area responsible for the VT, radiofrequency energy is delivered by the power generator through the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart tissue thought to cause the VT.
Read more
A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart rhythms from recurring.
The purpose of this study is to compare these two different methods for treating VT. Treatment with ablation and amiodarone are both considered the standard of care for patients with VT but they have not been compared directly in a study like this before.
- Being tested
- Ablation, Amiodarone
- Keywords
- Defibrillators, Implantable, Tachycardia, Ventricular, Catheter Ablation, Amiodarone
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Also called VT ablation, ischemic VT ablation, catheter ablation, radiofrequency ablation
Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization
AmiodaroneDrug
Also called Cordarone
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
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Active comparator | Catheter based radiofrequency ablation for ischemic ventricular tachycardia Receives: Procedure: Ablation |
| Amiodarone | Active comparator | 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. Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death
Number of participants with a composite outcome of any of:
- Appropriate Implantable Cardioverter Defibrillator (ICD) therapy [Including antitachycardia pacing (ATP) and shocks]
- Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation
- Sudden Cardiac Death
Measured: From 30 days following randomization until final follow-up visit
Secondary outcomes (2)
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.
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.
Measured: from randomization until final follow-up
Quality of Life Score
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.
Measured: At 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Anticipated non-feasibility of recruitment objectives
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.
- Other trials for Defibrillators, ImplantableStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Andrea Natale, M.D., Principal investigator, Texas Cardiac Arrhythmia Research FoundationDavid J Callans, M.D., Principal investigator, University of PennsylvaniaCarlos A. Morillo, M.D., Principal investigator, Population Health Research Institute, McMaster UniversityGirish M. Nair, M.D., Principal investigator, Population Health Research Institute, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097330
- Sponsor's protocol ID
- CEASE-VT
- Acronym
- CEASE-VT
- Status last verified
- Jan 2020
- First submitted
- 31 Mar 2010
- Last updated
- 29 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia: A Multi-center Randomized Trial
- ClinicalTrials.gov ID
- NCT01097330
- Acronym / sponsor ID
- CEASE-VT / CEASE-VT
- Keywords
- Defibrillators, Implantable, Tachycardia, Ventricular, Catheter Ablation, Amiodarone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Anticipated non-feasibility of recruitment objectives
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Hamilton Health Sciences Corporation
- Study start
- Aug 2010 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Apr 2010 (estimated)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This study is designed to determine the best way to manage patients who have an ICD and who continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and 2) Medication.
An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area and threading it into the heart. After the doctor has located the affected area responsible for the VT, radiofrequency energy is delivered by the power generator through the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart tissue thought to cause the VT.
A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart rhythms from recurring.
The purpose of this study is to compare these two different methods for treating VT. Treatment with ablation and amiodarone are both considered the standard of care for patients with VT but they have not been compared directly in a study like this before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation | Active comparator | Procedure: AblationCatheter based radiofrequency ablation for ischemic ventricular tachycardia |
| Amiodarone | Active comparator | Drug: Amiodaroneamiodarone 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. |
Who may qualify
- Ages
- 19 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AblationAlso: VT ablation, ischemic VT ablation, catheter ablation, radiofrequency ablationCatheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization | Procedure or surgery | Ablation |
| AmiodaroneAlso: CordaroneAmiodarone 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 | Drug | Amiodarone |
Primary outcome
Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death
Time frame: 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
2 secondary outcomes
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.
Time frame: from randomization until final follow-up
Quality of Life Score
Time frame: At 6 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Population Health Research InstituteLink provided by the sponsor.
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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.
Andrea Natale, M.D. principal investigator
Texas Cardiac Arrhythmia Research Foundation
David J Callans, M.D. principal investigator
University of Pennsylvania
Carlos A. Morillo, M.D. principal investigator
Population Health Research Institute, McMaster University
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ablation and Amiodarone in people with Defibrillators, Implantable and Tachycardia, Ventricular, run by Population Health Research Institute at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada, China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2020). 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?
Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death (time frame: From 30 days following randomization until final follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2020.