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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01294267
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Abiomed Inc.
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Device: Circulatory Support System Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PERcutaneous heModynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
Study Start Date : September 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: Impella 2.5 Circulatory Support system insertion

Primary Outcome Measures :
  1. Number of Participants With Procedural Success [ Time Frame: Inpatient Admission ]
    Satisfactory hemodynamic status during the ablation procedure [during VT Mapping and Ablation Procedure], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System

Secondary Outcome Measures :
  1. Clinical Outcomes [ Time Frame: 1 Month post ablation Follow up ]
    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.

Other Outcome Measures:
  1. Safety Outcomes [ Time Frame: 30 day ]

    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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01294267

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Vivek Reddy
Abiomed Inc.
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vivek Reddy, DIRECTOR CARDIAC ARRHYTHMIA SERVICE, PROFESSOR OF MEDICINE, Icahn School of Medicine at Mount Sinai Identifier: NCT01294267     History of Changes
Other Study ID Numbers: GCO 10-1423
BRANY IRB-10-02-154-05 ( Other Identifier: BRANY - Biomedical Research Alliance of New York, an institutional review board fully accredited by AAHRPP )
First Posted: February 11, 2011    Key Record Dates
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
Ventricular Tachycardia
Radio Frequency Ablation
Percutaneous Left Ventricular Assist Device
Hemodynamic Management
Interventional Cardiac Procedure
Mechanical Cardiac Assistance
Intra-Aortic Balloon Pump
Coronary Intervention
Impella 2.5
Circulation Support system

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes