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

This study has been completed.
Sponsor:
Collaborator:
Abiomed Inc.
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01294267
First received: January 25, 2011
Last updated: March 23, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Ventricular Tachycardia
Device: Impella 2.5 Circulatory Support system insertion
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: PERcutaneous heModynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Hemodynamic Support of Impella 2.5 Circulatory Support System [ Time Frame: Inpatient Admission ] [ Designated as safety issue: No ]
    This study will assess whether there is a satisfactory hemodynamic status during the ablation procedure [during VT Mapping and Ablation Procedure], and whether there is any need for additional circulatory support following the procedure


Secondary Outcome Measures:
  • Morbidity and Mortality [ Time Frame: Month [30 Days] Follow up ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Impella 2.5 Circulatory Support system insertion
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294267

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Vivek Reddy
Abiomed Inc.
Investigators
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vivek Reddy, DIRECTOR CARDIAC ARRHYTHMIA SERVICE, PROFESSOR OF MEDICINE, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01294267     History of Changes
Other Study ID Numbers: GCO 10-1423, BRANY IRB-10-02-154-05
Study First Received: January 25, 2011
Last Updated: March 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
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
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014