Ischemic Ventricular TachycardiaPhase 1DSMNCT00558857
Dynamic Substrate Mapping (DSM) for Ischemic VT
A Phase 1 study testing Dynamic Substrate Mapping-guided ablation in people with Ischemic Ventricular Tachycardia, run by Abbott Medical Devices at 3 sites in United States.
Trial summary
This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Ventricular Tachycardia
- What is being tested?
- Dynamic Substrate Mapping-guided ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2007to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have an ICD or CRT-D device
- Had at least 3 documented device therapies to treat VT over last 3 months
- Clinical VT is confirmed or suspected to be of ischemic origin
- Scheduled for VT ablation procedure
- LVEF > or = 20%
Who cannot join
- Inadequate AAD washout (amiodarone should be maintained at current dose)
- Unstable angina
- Active ischemia
- Cardiac surgery within prior 2 months
- Evidence of infection
- Prosthetic mitral or aortic valve or mitral/aortic valvular heart disease requiring surgical intervention
Show all 14Show fewer
- History of embolic event
- Myocardial infarction within prior 6 weeks
- Enrolled in another study
- Recurrent sepsis or otherwise not a candidate for catheterization
- Hypercoagulable state or inability to tolerate heparin therapy during procedure
- Has had an atriotomy or ventriculotomy within prior 4 months
- Life expectancy < 6 months
- Class IV NYHA classification
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois
Sentara Norfolk General Hospital
Norfolk, Virginia
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania
About this study
Official title: Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia
This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Results from this study will be used to determine if further clinical investigation is warranted.
- Conditions
- Ischemic Ventricular Tachycardia
- Being tested
- Dynamic Substrate Mapping-guided ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Substrate Mapping-guided ablationDevice
Radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| DSM | Active comparator | Treatment using DSM to guide ablation Receives: Device: Dynamic Substrate Mapping-guided ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events (SAEs)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Callans, MD, Principal investigator, University of PennsylvaniaJason Jacobson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558857
- Sponsor's protocol ID
- 065.5
- Acronym
- DSM
- Status last verified
- Feb 2019
- First submitted
- 14 Nov 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT00558857
- Acronym / sponsor ID
- DSM / 065.5
- Conditions
- Ischemic Ventricular Tachycardia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Results from this study will be used to determine if further clinical investigation is warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSM | Active comparator | Device: Dynamic Substrate Mapping-guided ablationTreatment using DSM to guide ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have an ICD or CRT-D device
- Had at least 3 documented device therapies to treat VT over last 3 months
- Clinical VT is confirmed or suspected to be of ischemic origin
- Scheduled for VT ablation procedure
- LVEF > or = 20%
Key exclusion criteria (14 listed)
- Inadequate AAD washout (amiodarone should be maintained at current dose)
- Unstable angina
- Active ischemia
- Cardiac surgery within prior 2 months
- Evidence of infection
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 |
|---|---|---|
| Dynamic Substrate Mapping-guided ablationRadiofrequency ablation | Device | DSM |
Primary outcome
Incidence of serious adverse events (SAEs)
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Related trials for Ischemic Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingObservational study
The Multicenter Cardiology Monitoring Platform Registry
Heart Failure, Cardiomyopathies
Not yet recruiting
Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program VERITAS SCAR VT
Scar-related Monomorphic Sustained VT
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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 principal investigator
University of Pennsylvania
Jason Jacobson, MD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dynamic Substrate Mapping-guided ablation in people with Ischemic Ventricular Tachycardia, run by Abbott Medical Devices at 3 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 5 inclusion and 14 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Incidence of serious adverse events (SAEs) (time frame: 30 days). 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 4 Feb 2019.