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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01294267
Other study ID # GCO 10-1423
Secondary ID BRANY IRB-10-02-
Status Completed
Phase N/A
First received January 25, 2011
Last updated January 17, 2018
Start date September 2010
Est. completion date January 2012

Study information

Verified date January 2018
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Mount Sinai School of Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
Vivek Reddy Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety Outcomes Acute Kidney Injury Network stage 1 kidney injury (ie, an absolute increase in serum creatinine of =0.3 mg/dL or percentage increase of 150%-200% from baseline.
A decline in neurocognitive function, as defined by a decrease in MMSE =2 points from the baseline score, after the procedure.
30 day
Primary Number of Participants With Procedural Success Satisfactory hemodynamic status during the ablation procedure [during VT Mapping and Ablation Procedure], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System Inpatient Admission
Secondary Clinical Outcomes Morbidity and Mortality, as determined by clinical metrics and validated by tests during and immediately post VT Mapping and ablation procedure with cardiac monitoring in hospital and one Month [30 days] follow up telephone interview to assess symptoms, side effects and medication use. 1 Month post ablation Follow up
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