Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the safety and feasibility of the Impella 2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia in the setting of Ventricular dysfunction.

Detailed Description
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The Impella 2.5 is a percutaneous heart pump that will be used to provide partial circulatory support -. The Impella 2.5 is approved by the US Food and Drug Administration and is being tested to see if it helps keep the patient's blood pressure stable during the cardiac ablation procedure. The Impella 2.5 Circulatory Support System works by placing a small pump into the left pumping chamber of the heart which will then help the heart circulate blood throughout the body. The Impella 2.5 Circulatory Support system will be removed once the heart no longer needs help with the pumping action which can be at any time from just after the completion of the heart procedure up to several days post procedure as determined by physician.

Official Title
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PERcutaneous heModynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Circulatory Support System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female age 18 to 90 years catheter ablation of ventricular tachycardia Left Ventricular ejection fraction less than or equal to 40% or hypertrophic cardiomyopathy Exclusion Criteria: Any reversible cause of VT [electrolyte derangements, medication related itc] Evidence of active, ongoing cardiac ischemia as the cause of VT Patients who have experienced any cerebral ischemic event including any TIA in the preceding one month Mural thrombus in left Ventricle Presence of mechanical aortic valve Severe Aortic Stenosis [orifice area of 2.0 cm2 or less] or moderate to severe aortic insufficiency Severe abnormalities of the aorta that would preclude Impella insertion, including aneurysms and extreme tortuosity or calcifications Liver dysfunction or markedly abnormal coagulation parameters [as defined by platelet count less than or equal to 50,000/ul] Any condition resulting in contraindication to anticoagulation [eg GI bleeding] Women who are known to be pregnant or have had a positive B-HCG test 7 days prior to procedure Patients whose life expectancy is less than one year Mental Impairment precluding patient or family from providing informed consent or completing the appropriate follow up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Circulatory Support System<br>Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion. | Device: Circulatory Support System<br>* Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects<br>* Other names: Impella 2.5 Circulatory Support system insertion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Procedural Success | Satisfactory hemodynamic status during the ablation procedure [during VT Mapping and Ablation Procedure], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System | Inpatient Admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes | Morbidity and Mortality, as determined by clinical metrics and validated by tests during and immediately post VT Mapping and ablation procedure with cardiac monitoring in hospital and one Month [30 days] follow up telephone interview to assess symptoms, side effects and medication use. | 1 Month post ablation Follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Tachycardia, Radio Frequency Ablation, Percutaneous Left Ventricular Assist Device, Hemodynamic Management, Interventional Cardiac Procedure, Mechanical Cardiac Assistance, Intra-Aortic Balloon Pump, Coronary Intervention, Impella 2.5, Circulation Support system