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

NCT ID: NCT01294267

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Circulatory Support System

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.

Group Type: OTHER

Circulatory Support System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Impella 2.5 Circulatory Support system insertion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: collaborator

Vivek Reddy

OTHER

Sponsor Role: lead

Responsible Party

Vivek Reddy

DIRECTOR CARDIAC ARRHYTHMIA SERVICE, PROFESSOR OF MEDICINE

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vivek Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

References

Miller MA, Dukkipati SR, Chinitz JS, Koruth JS, Mittnacht AJ, Napolitano C, d'Avila A, Reddy VY. Percutaneous hemodynamic support with Impella 2.5 during scar-related ventricular tachycardia ablation (PERMIT 1). Circ Arrhythm Electrophysiol. 2013 Feb;6(1):151-9. doi: 10.1161/CIRCEP.112.975888. Epub 2012 Dec 19.

Reference Type: DERIVED

PMID: 23255277 (View on PubMed)

Other Identifiers

BRANY IRB-10-02-154-05

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 10-1423

Identifier Type: -

Identifier Source: org_study_id