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

NCT01294267 | Completed Results DMC

• 2 other identifiers: GCO 10-1423BRANY IRB-10-02-154-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Outcomes

  1 Month post ablation Follow up

Other Outcomes (1)

• Safety Outcomes

  30 day

Study Arms (1)

Circulatory Support System

OTHER

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

Interventions

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

Also known as: Impella 2.5 Circulatory Support system insertion

Circulatory Support System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivek Reddy: lead
• Abiomed Inc.: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 23255277 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The lack of a control group precludes drawing definitive conclusions between the lack of either statistically or clinically significant changes in perioperative markers of end-organ perfusion/function and the use of a pLVAD.

Results Point of Contact

• Title: Vivek Y. Reddy, MD
• Organization: Icahn School of Medicine at Mount Sinai, Helmsley Electrophysiology Center

vivek.reddy@mountsinai.org

212-241-7114

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DIRECTOR CARDIAC ARRHYTHMIA SERVICE, PROFESSOR OF MEDICINE

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: February 11, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 14, 2018
• Results First Posted: February 14, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)