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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Circulatory Support System	Circulatory Support System	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Success	Inpatient Admission	Satisfactory hemodynamic status during the ablation procedure \[during VT Mapping and Ablation Procedure\], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes	1 Month post ablation Follow up	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.