Clinical trial NCT01294267: Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
Official title: PERcutaneous heModynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: 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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Abiomed Inc.
First posted: 2011-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Procedural Success
timeFrame: Inpatient Admission
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: 1 Month post ablation Follow up
Other outcomes:
measure: Safety Outcomes
timeFrame: 30 day
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller MA, Dukkipati SR, Chinitz JS, Koruth JS, Mittnacht AJ, Napolitano C, d'Avila A, Reddy VY. Percutaneous hemodynamic support with Impella 2.5 during scar-related ventricular tachycardia ablation (PERMIT 1). Circ Arrhythm Electrophysiol. 2013 Feb;6(1):151-9. doi: 10.1161/CIRCEP.112.975888. Epub 2012 Dec 19.