Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
Completed · Not applicable
Conditions studied: Ventricular Tachycardia
In brief
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.
Key facts
- Study ID
- NCT01294267
- Run by
- Vivek Reddy
- People needed
- 20
- Starts
- 2010-09-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2018-02-14
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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