Ischemic Ventricular Tachycardia
Conditions
Brief 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.
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.
Interventions
DEVICETherapy Cool Path Duo Cardiac Ablation System
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.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure. | 7 days |
Countries
United States
Participant flow
Recruitment details
Patients with atrial flutter are evaluated by ablation doctor in the EP clinic and assessed for possibility of meeting other inclusion criteria.
Pre-assignment details
This is a non-randomized study.
Participants by arm
| Arm | Count |
|---|---|
| Therapy Cool Path Duo Cardiac Ablation System Therapy Cool Path Duo Cardiac Ablation System: Consists three system components:
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.
The 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.
The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study closed -- business decision | 20 |
Baseline characteristics
| Characteristic | Therapy Cool Path Duo Cardiac Ablation System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 66.8 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 20 |
| serious Total, serious adverse events | 7 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Therapy Cool Path Duo Catheter | Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure. | 7 participants |