CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Circulatory Support Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01294267
NCT01294267N/ACompleted
CompareCT.gov

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

Vivek Reddy·interventional·Posted Feb 11, 2011·Updated Feb 14, 2018

In Brief

A clinical study evaluating Circulatory Support System for Ventricular Tachycardia. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Tachycardia
CountriesUnited States
CollaboratorsAbiomed Inc.

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2011
Enrollment StartSep 1, 2010
Primary CompletionAug 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.4 years ago

Interventions

Circulatory Support Systemdevice

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