NCT01294267

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Circulatory Support System	Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-08-01
• Completion: 2012-01-01
• First posted: 2011-02-11
• Last updated: 2018-02-14
• Results posted: 2018-02-14

Locations

1 site across 1 country: United States