Ventricular TachycardiaPhase 4ASPIRENCT01557842
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
A Phase 4 study testing Drug Treatment and Catheter Ablation in people with Ventricular Tachycardia and Ischemic, run by Biosense Webster, Inc. at 23 sites in United States.
Trial summary
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ischemic
- What is being tested?
- Drug Treatment and Catheter Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 23 sitesUnited States
- Study dates
- 1 Jun 2012to 19 Mar 2014
- Phase
- Phase 4
- 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
- Subject must be drug refractory on Class I-IV AADs (i.e., having VT episodes despite drug therapy)
- Subject must be on at least one AAD at time of enrollment
- Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction
- ICD implanted
- 1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator
- History of myocardial infarction documented by the development of pathological Q waves with or without symptoms, imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract in the absence of a nonischemic cause, or pathological findings of a healed or healing myocardial infarction
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- 18 years or older
- Able and willing to comply with all pre- and follow-up testing and requirements
- Signed Informed Consent Form
Who cannot join
- Age < 18 years
- Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram
- Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours)
- Contraindication to anticoagulation
- NYHA class IV
- Left ventricular assist devices (LVADs) or other circulatory assist devices
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- Stroke as confirmed by plasma d-dimer levels or acute myocardial infarction as documented by electrocardiogram or cardiac imaging within the past three (3) months. (Note that a small cardiac enzyme release resulting from being in VT/shocks/etc. is not considered a myocardial infarction.)
- Patients with active ischemia who are eligible for revascularization
- Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy)
- Other disease process likely to limit survival to less than 12 months
- Serum creatinine of ≥ 2.5mg/dl
- Thrombocytopenia or coagulopathy
- Prior ablation for Ventricular Tachycardia
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
- Enrollment in an study evaluating an investigational device or drug
- Unable or unwilling to comply with protocol requirements
- Exclusively Polymorphic Ventricular Tachycardia
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado, Denver
Aurora, Colorado, 80045
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02199
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Central Baptist Hospital
Lexington, Kentucky, 40503
University of California, Los Angeles
Los Angeles, California, 90095
Loyola University Chicago
Maywood, Illinois, 60153
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University- New York Presbyterian Hospital
New York, New York, 10032
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Florida Hospital
Orlando, Florida, 32803
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55902
California Pacific Medical Center
San Francisco, California, 94115
San Francisco VA Medical Center
San Francisco, California, 94121
University of California, San Francisco
San Francisco, California, 94143
About this study
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.
- Conditions
- Ventricular Tachycardia, Ischemic
- Being tested
- Drug Treatment, Catheter Ablation
- Keywords
- Ischemic, Ventricular Tachycardia, Implantable Cardioverter Defibrillators, Antiarrhythmic Drug Therapy, Ablation, Electrophysiology
- Medical subject headings
- Tachycardia, Ventricular, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug TreatmentDrug
Class I and III antiarrhythmic drug treatment.
Catheter AblationDevice
Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | This group receives radiofrequency catheter ablation and drug treatment. Receives: Device: Catheter Ablation |
| Control Group | Experimental | This group receives only drug treatment. Receives: Drug: Drug Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events
The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.
Measured: From one month to 2 years follow up
Cardiac-related Death
Subjects with cardiac-related death
Measured: 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study start1 Jun 2012
- Primary completion19 Mar 2014
- Study completion19 Mar 2014
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 Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Callans, MD, Study chair, University of PennsylvaniaFrancis Marchlinski, MD, Study chair, University of PennsylvaniaAndrea Natale, MD, Study chair, Texas Cardiac Arrhythmia Research FoundationVivek Reddy, MD, Study chair, Icahn School of Medicine at Mount SinaiDavid Wilber, MD, Study chair, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557842
- Sponsor's protocol ID
- ASPIRE
- Acronym
- ASPIRE
- Status last verified
- May 2017
- First submitted
- 16 Mar 2012
- Last updated
- 8 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
- ClinicalTrials.gov ID
- NCT01557842
- Acronym / sponsor ID
- ASPIRE / ASPIRE
- Conditions
- Ventricular Tachycardia, Ischemic
- Keywords
- Ischemic, Ventricular Tachycardia, Implantable Cardioverter Defibrillators, Antiarrhythmic Drug Therapy, Ablation, Electrophysiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 19 Mar 2014 (actual)
- Study completion
- 19 Mar 2014 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Posted 1 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Device: Catheter AblationThis group receives radiofrequency catheter ablation and drug treatment. |
| Control Group | Experimental | Drug: Drug TreatmentThis group receives only drug treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be drug refractory on Class I-IV AADs (i.e., having VT episodes despite drug therapy)
- Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction
- ICD implanted
- 1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator
- History of myocardial infarction documented by the development of pathological Q waves with or without symptoms, imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract in the absence of a nonischemic cause, or pathological findings of a healed or healing myocardial infarction
Key exclusion criteria (17 listed)
- Age < 18 years
- Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram
- Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours)
- Contraindication to anticoagulation
- NYHA class IV
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 |
|---|---|---|
| Drug TreatmentClass I and III antiarrhythmic drug treatment. | Drug | Control Group |
| Catheter AblationRadiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment. | Device | Treatment Group |
Primary outcome
Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events
Time frame: From one month to 2 years follow up
The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.
Cardiac-related Death
Time frame: 2 years follow up
Subjects with cardiac-related death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
David Callans, MD study chair
University of Pennsylvania
Francis Marchlinski, MD study chair
University of Pennsylvania
Andrea Natale, MD study chair
Texas Cardiac Arrhythmia Research Foundation
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug Treatment and Catheter Ablation in people with Ventricular Tachycardia and Ischemic, run by Biosense Webster, Inc. at 23 sites in United States.
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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 1 Jan 2015). 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?
Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events (time frame: From one month to 2 years follow up). The study lists 2 primary outcomes in all. 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 8 Jun 2017.