Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

Sponsor

William Stevenson (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01791543

Collaborator

(none)

Enrollment

Locations

Arm

71.8

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia	Device: Intramural Needle Ablation Catheter	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

May 27, 2022

Anticipated Study Completion Date :

Aug 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intramural Needle Catheter Ablation Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter	Device: Intramural Needle Ablation Catheter

Arm

Intervention/Treatment

Experimental: Intramural Needle Catheter Ablation

Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter

Device: Intramural Needle Ablation Catheter

Outcome Measures

Primary Outcome Measures

Control of Ventricular Tachycardia (VT) [6 months]
Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation.
Absence of all serious adverse events [30 days]
Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure
Reduction of ventricular arrhythmia causing significant ventricular dysfunction [6 months]
decrease in ambient ventricular arrhythmia to < 5000 ventricular beats daily

Secondary Outcome Measures

Acute Procedural Success [Absence of inducible clinical VT at then end of the ablation procedure.]
Defined as termination of at least one clinical or presumptive clinical monomorphic VT by Radiofrequency ablation and/or rendering that VT no longer inducible. It is recognized that this secondary efficacy endpoint will not be assessed in all patients because VT induction will not be attempted in patients in whom, in the judgment of the investigator, attempted VT induction imposes unwarranted risk of hemodynamic deterioration. A clinical or presumptive clinical VT is one that has been documented to occur spontaneously, or is within 20 ms in cycle length of a VT that has been documented to occur spontaneously.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 50%

Arrhythmia meet the following criteria:

Ventricular arrhythmia is recurrent and symptomatic
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

William Stevenson

Investigators

Study Director: William G. Stevenson, M.D., Vanderbilt Heart and Vascular Institute
Principal Investigator: Usha Tedrow, M.D., Brigham and Women's Hospital