Ischemic Ventricular TachycardiaAblate-VTNCT00925522
Therapy Cool Path Ablate VT
A study testing Therapy Cool Path Duo Cardiac Ablation System in people with Ischemic Ventricular Tachycardia, run by Abbott Medical Devices at 5 sites in United States.
Trial summary
To demonstrate that ablation with the Therapy Cool Path Duo cardiac ablation system can eliminate ischemic VT and that its use does not result in an unacceptable risk of serious adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Ventricular Tachycardia
- What is being tested?
- Therapy Cool Path Duo Cardiac Ablation System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2009to Jul 2011
- 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 18 years of age or older
- Patient has an ICD (Implantable Cardiac Defibrillator) or will be implanted with one prior to discharge of ablation procedure
- Patient has had at least 2 documented spontaneous episode of sustained ischemic VT (Ventricular Tachycardia) within the previous 6 months
- Patient is resistant, intolerant or refractory to at least one Class I or III AAD (Anti-Arrhythmic Drug)
- Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board
Who cannot join
- Non-ischemic VT
- History of stroke or transient ischemic attack within 6 months prior to enrollment
- MI or previous cardiac surgery within 2 months prior to enrollment
- Patient is pregnant or nursing
- Patient has chronic NYHA (New York Heart Association) class IV heart failure
- Limited life expectancy of 6 months or less
Show all 12Show fewer
- Patient is currently participating in another investigational drug or device study
- Patient is unable or unwilling to cooperate with the study procedures
- Known presence of intracardiac thrombi
- Severe aortic stenosis or flailed mitral valve
- Major contraindication to anticoagulation therapy or coagulation disorder
- Left Ventricular Ejection Fraction <10%
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
Kansas University Medical Center
Kansas City, Kansas, 66160
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Clinical Evaluation of Therapy Cool Path Duo Cardiac Ablation System for the Treatment of Ischemic Ventricular Tachycardia (VT)
To demonstrate that ablation with the Therapy Cool Path Duo cardiac ablation system can eliminate ischemic VT and that its use does not result in an unacceptable risk of serious adverse events.
Read the detailed description
Ventricular Tachycardia (VT) is a common complication of ischemic heart disease that is often life threatening. Ventricular tachycardia is defined as three or more beats of ventricular origin in succession at a rate greater than 100 beats per minute. There are no normal QRS complexes associated with VT, and the rhythm is usually regular. Patients with VT experience unpleasant heart palpitations, dyspnea, and syncope, all of which decrease their overall quality of life. They also suffer the consequences of impaired hemodynamics, loss of cardiac efficiency, and are at an increased risk of sudden cardiac death (SCD), which accounts for approximately half of all deaths from patients with cardiovascular disease.
Historically, antiarrhythmic medications served as the first line therapy for the treatment of VT, in spite of low efficacy and high recurrence rates. But in recent years, internal cardioverter defibrillators (ICDs) have become the treatment of choice. Although, ICDs are effective in terminating most arrhythmias, rarely does so without some episodes requiring poorly tolerated shock therapy. Ablative therapy offers an important option for frequent control with the potential for long-term VT elimination. Radiofrequency catheter ablation offers the ability to provide immediate control of recurrent VT. Since the early 2000's, strategies, tools, and techniques have been improving to identify key ablation sites and to deliver effective lesions.
Radiofrequency ablation is successful in treating some but not all arrhythmias. With non irrigated technology it has been difficult to ablate ischemic VT. This may be due to an inadequate lesion size. Irrigated electrodes were developed to create larger lesions. Open irrigation at the catheter tip not only produces larger lesions, but also helps reduce the risk of coagulum (clots) and charring due to high temperatures.
- Conditions
- Ischemic Ventricular Tachycardia
- Being tested
- Therapy Cool Path Duo Cardiac Ablation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy Cool Path Duo Cardiac Ablation SystemDevice
Cardiac Ablation Procedure for Ischemic VT using a flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.
1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.
| Study group | Role | What they receive |
|---|---|---|
| Therapy Cool Path Duo Cardiac Ablation System | Experimental | All patients who are eligible receive cardiac ablation procedure for Ischemic Ventricular Tachycardia Receives: Device: Therapy Cool Path Duo Cardiac Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionJul 2011
Why it stopped: Study data no longer needed
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- G. Neal Kay, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925522
- Sponsor's protocol ID
- G080076
- Acronym
- Ablate-VT
- Status last verified
- Apr 2019
- First submitted
- 8 Jun 2009
- Last updated
- 17 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Therapy Cool Path Duo Cardiac Ablation System for the Treatment of Ischemic Ventricular Tachycardia (VT)
- ClinicalTrials.gov ID
- NCT00925522
- Acronym / sponsor ID
- Ablate-VT / G080076
- Conditions
- Ischemic Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study data no longer needed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Posted 27 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that ablation with the Therapy Cool Path Duo cardiac ablation system can eliminate ischemic VT and that its use does not result in an unacceptable risk of serious adverse events.
Detailed description
Ventricular Tachycardia (VT) is a common complication of ischemic heart disease that is often life threatening. Ventricular tachycardia is defined as three or more beats of ventricular origin in succession at a rate greater than 100 beats per minute. There are no normal QRS complexes associated with VT, and the rhythm is usually regular. Patients with VT experience unpleasant heart palpitations, dyspnea, and syncope, all of which decrease their overall quality of life. They also suffer the consequences of impaired hemodynamics, loss of cardiac efficiency, and are at an increased risk of sudden cardiac death (SCD), which accounts for approximately half of all deaths from patients with cardiovascular disease.
Historically, antiarrhythmic medications served as the first line therapy for the treatment of VT, in spite of low efficacy and high recurrence rates. But in recent years, internal cardioverter defibrillators (ICDs) have become the treatment of choice. Although, ICDs are effective in terminating most arrhythmias, rarely does so without some episodes requiring poorly tolerated shock therapy. Ablative therapy offers an important option for frequent control with the potential for long-term VT elimination. Radiofrequency catheter ablation offers the ability to provide immediate control of recurrent VT. Since the early 2000's, strategies, tools, and techniques have been improving to identify key ablation sites and to deliver effective lesions.
Radiofrequency ablation is successful in treating some but not all arrhythmias. With non irrigated technology it has been difficult to ablate ischemic VT. This may be due to an inadequate lesion size. Irrigated electrodes were developed to create larger lesions. Open irrigation at the catheter tip not only produces larger lesions, but also helps reduce the risk of coagulum (clots) and charring due to high temperatures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy Cool Path Duo Cardiac Ablation System | Experimental | Device: Therapy Cool Path Duo Cardiac Ablation SystemAll patients who are eligible receive cardiac ablation procedure for Ischemic Ventricular Tachycardia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is 18 years of age or older
- Patient has an ICD (Implantable Cardiac Defibrillator) or will be implanted with one prior to discharge of ablation procedure
- Patient has had at least 2 documented spontaneous episode of sustained ischemic VT (Ventricular Tachycardia) within the previous 6 months
- Patient is resistant, intolerant or refractory to at least one Class I or III AAD (Anti-Arrhythmic Drug)
- Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board
Key exclusion criteria (12 listed)
- Non-ischemic VT
- History of stroke or transient ischemic attack within 6 months prior to enrollment
- MI or previous cardiac surgery within 2 months prior to enrollment
- Patient is pregnant or nursing
- Patient has chronic NYHA (New York Heart Association) class IV heart failure
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 |
|---|---|---|
| Therapy Cool Path Duo Cardiac Ablation SystemCardiac Ablation Procedure for Ischemic VT using a flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation. 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode. | Device | Therapy Cool Path Duo Cardiac Ablation System |
Primary outcome
Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure.
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ischemic Ventricular Tachycardia
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The Multicenter Cardiology Monitoring Platform Registry
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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
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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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.
G. Neal Kay, M.D. principal investigator
University of Alabama at Birmingham
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy Cool Path Duo Cardiac Ablation System in people with Ischemic Ventricular Tachycardia, run by Abbott Medical Devices at 5 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 12 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2016). 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?
Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure. (time frame: 7 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 17 Apr 2019.