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

Ventricular Tachycardia Clinical Trial

— PERMIT1  

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

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