Status:
COMPLETED
Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia
Lead Sponsor:
William Stevenson
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 vent...
Eligibility Criteria
Inclusion
- Monomorphic ventricular tachycardia (VT) 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 left ventricular (LV) ejection fraction to less than 0.50.
- Arrhythmia meets the following criteria:
- Ventricular arrhythmia is recurrent and symptomatic
- prior antiarrhythmic drug therapy has failed due to recurrent ventricular arrhythmia, toxicity, or intolerance
- Age 18 or older
- Left ventricular (LV) ejection fraction \> 0.10 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
- 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
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01791543
Start Date
September 1 2016
End Date
May 27 2022
Last Update
February 1 2023
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States, 37232