Ventricular TachycardiaSTRATUM VTNCT01546207
Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
A study testing catheter-based ablation in people with Ventricular Tachycardia and Catheter Ablation, run by Vivek Reddy at 10 sites in 5 countries.
Trial summary
The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Tachycardia, Catheter Ablation, Tachycardia, Ventricular
- What is being tested?
- catheter-based ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Sep 2011to Aug 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 90 years.
- History of coronary artery disease.
- Presence of, or planned for, an ICD prior to discharge.
- Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia.
Who cannot join
- Ventricular arrhythmia not thought to be due to CAD.
- Unstable angina
- CVA within 30 days.
- Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography
- Pregnancy
- Any condition resulting in an absolute contraindication to anticoagulation
Show all 11Show fewer
- Inability to follow-up at ICD clinic.
- Inability to give informed consent.
- Non-inducible for sustained monomorphic ventricular tachycardia.
- Prior substrate guided ablation.
- Definite need for epicardial ablation, as determined by the primary operator.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
United States6 sites
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel-Deaconess Medical Center
Boston, Massachusetts, 02215
Loyola University
Maywood, Illinois, 60153
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.
Read the detailed description
Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.
- Being tested
- catheter-based ablation
- Keywords
- ventricular tachycardia, catheter ablation, VT
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter-based ablationProcedure or surgery
specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia
| Study group | Role | What they receive |
|---|---|---|
| catheter-based ablation | Other | catheter ablation - a medical procedure used to treat some types of arrhythmia Receives: Procedure: catheter-based ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter Ablation
The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia
Measured: at time of catheter ablation procedure (intraoperative)
Secondary outcomes (3)
ICD Interrogation
Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.
Measured: baseline and 6 months follow-up
Procedural Safety
- Procedural safety as defined by the number of complication within 1week associated with the procedure.
Measured: 1 week post-op
Signal-Average ECG
Relationship between change in pre/post saECG and success of the step-wise ablation strategy
Measured: baseline and post-op day one after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: low enrollment
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546207
- Sponsor's protocol ID
- GCO 12-0045
- Acronym
- STRATUM VT
- Status last verified
- Dec 2019
- First submitted
- 13 Feb 2012
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT01546207
- Acronym / sponsor ID
- STRATUM VT / GCO 12-0045
- Keywords
- ventricular tachycardia, catheter ablation, VT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 24 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.
Detailed description
Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| catheter-based ablation | Other | Procedure: catheter-based ablationcatheter ablation - a medical procedure used to treat some types of arrhythmia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 90 years.
- History of coronary artery disease.
- Presence of, or planned for, an ICD prior to discharge.
- Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia.
Key exclusion criteria (11 listed)
- Ventricular arrhythmia not thought to be due to CAD.
- Unstable angina
- CVA within 30 days.
- Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography
- Pregnancy
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 |
|---|---|---|
| catheter-based ablationspecific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia | Procedure or surgery | catheter-based ablation |
Primary outcome
Catheter Ablation
Time frame: at time of catheter ablation procedure (intraoperative)
The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia
3 secondary outcomes
ICD Interrogation
Time frame: baseline and 6 months follow-up
Procedural Safety
Time frame: 1 week post-op
Signal-Average ECG
Time frame: baseline and post-op day one after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic 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
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter-based ablation in people with Ventricular Tachycardia and Catheter Ablation, run by Vivek Reddy at 10 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 4 inclusion and 11 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 13 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 10 sites in United States, Brazil, Canada, Czechia, Italy. 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 24 Apr 2014). 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?
Catheter Ablation (time frame: at time of catheter ablation procedure (intraoperative)). 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 13 Jan 2020.