Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation (PERMIT1)

Vivek Reddy

Status: Completed

Conditions: Ventricular Tachycardia

Treatments: Device: Circulatory Support System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01294267

GCO 10-1423

BRANY IRB-10-02-154-05 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Circulatory Support System

Other group

Description:

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.

Treatment:

Device: Circulatory Support System