Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/28/2018
Start Date:September 2016
End Date:September 2019
Contact:Sherry Bowman, MSN/MHSA
Email:sherry.bowman@vumc.org
Phone:615-936-0061

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Early Feasibility Study of Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation

The purpose of the study is to assess the effectiveness and safety of a new device called an
Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and
ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This
approach is desirable because some people have ventricular arrhythmias that originate deep
within the heart muscle where it is not abolished by ablation with standard catheters.

The investigators seek to determine whether the INA catheter can potentially help people who
have ventricular arrhythmias that have failed standard radiofrequency ablation. The
investigators also want to determine if it is likely to be safe, without excessive side
effects.


Inclusion Criteria:

Monomorphic ventricular tachycardia or incessant ventricular arrhythmia (defined as >20% of
beats due to ventricular arrhythmia including unifocal premature ventricular contractions
(PVCs ), couplets, nonsustained VT) that is causing a decline in LV ejection fraction to
less than 40%

Arrhythmia meet the following criteria:

1. Ventricular arrhythmia is recurrent and symptomatic

2. prior antiarrhythmic drug therapy has failed due to recurrent ventricular arrythmia,
toxicity, or intolerance

- Age 18 or older

- Left ventricular (LV) ejection fraction > 10% as estimated by echocardiography or
contrast ventriculography within the previous 90 days

- Failed prior VT or PVC ablation due to spontaneous recurrence of the arrhythmia
or frequent PVCs.

- Able and willing to comply with all pre-, post-, and follow-up testing and
requirements

- Signed Informed Consent

Exclusion Criteria:

- Patients with idiopathic VT defined as VT that originates from a region without
evidence of scar detected by MRI or voltage mapping in a patient without other
evidence of heart disease that is not causing significant depression of ventricular
function.

- Definite protruding left ventricular thrombus on pre-ablation echocardiography when LV
ablation is required.

- Thrombotic myocardial infarction within the preceding two (2) months.

- Other disease process that is likely to limit survival to less than 12 months.

- Class IV heart failure, unless heart failure is due to frequent or incessant VT.

- Contraindication to heparin.

- Allergy to radiographic contrast dye.

- Severe aortic stenosis

- Severe mitral regurgitation with a flail mitral valve leaflet.

- Significant congenital anomaly or medical problem that in the opinion of the principal
investigator would preclude enrollment into the study.

- Enrolled in another investigational study evaluating a drug or device.

- Unstable angina that is not due to frequent or incessant VT.

- Women who are pregnant.

- Thrombocytopenia (platelet count < 50,000) or coagulopathy.

- Acute non-cardiovascular illness or systemic infection.

- Cardiogenic shock unless it is due to incessant VT
We found this trial at
2
sites
Nashville, Tennessee 37232
Phone: 615-936-7537
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Usha Tedrow, M.D.
Phone: 857-307-1947
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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