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

Primary Purpose

Ventricular Tachycardia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Circulatory Support System

About this trial

This is an interventional supportive care trial for Ventricular Tachycardia focused on measuring 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

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Circulatory Support System

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01294267

First Posted

January 25, 2011

Last Updated

January 17, 2018

Sponsor

Vivek Reddy

Collaborators

Abiomed Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01294267

Brief Title

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

Acronym

PERMIT1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Vivek Reddy

Collaborators

Abiomed Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Tachycardia

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Circulatory Support System

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Circulatory Support System

Other Intervention Name(s)

Impella 2.5 Circulatory Support system insertion

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Procedural Success

Description

Satisfactory hemodynamic status during the ablation procedure [during VT Mapping and Ablation Procedure], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System

Time Frame

Inpatient Admission

Secondary Outcome Measure Information:

Title

Clinical Outcomes

Description

Time Frame

1 Month post ablation Follow up

Other Pre-specified Outcome Measures:

Title

Safety Outcomes

Description

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.

Time Frame

30 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vivek Reddy, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23255277

Citation

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.

Results Reference

derived

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

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