Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation (PERMIT1)

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

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 Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: Circulatory Support System

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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.

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; Other Names: Impella 2.5 Circulatory Support system insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Collaborators: Abiomed Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (ESTIMATE): February 11, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Coronary Intervention; Ventricular Tachycardia; Radio Frequency Ablation; Hemodynamic Management; Percutaneous Left Ventricular Assist Device; Interventional Cardiac Procedure; Mechanical Cardiac Assistance; Intra-Aortic Balloon Pump; Impella 2.5; Circulation Support system
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: GCO 10-1423; BRANY IRB-10-02-154-05 (OTHER: BRANY - Biomedical Research Alliance of New York, an institutional review board fully accredited by AAHRPP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO