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Completed

NCT Number: NCT01294267

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circulatory Support System

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

Other names: Impella 2.5 Circulatory Support system insertion

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vivek Reddy

Other

Collaborators

  • Abiomed Inc.

Registry information

Acronym: PERMIT1

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 11, 2011
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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