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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:2/16/2018
Start Date:September 2010
End Date:January 2012

Use our guide to learn which trials are right for you!

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

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.

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.

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
We found this trial at
1
site
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials