Ventricular Tachycardia
Conditions
Keywords
ventricular tachycardia, ablation, ventricular arrhythmia
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.
Interventions
DEVICEIntramural Needle Ablation Catheter
Sponsors
William Stevenson
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: 1. Ventricular arrhythmia is recurrent and symptomatic 2. 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months | 6 months | Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation for VT. |
| Number of Participants With No Serious Adverse Events | 30 days | Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure |
| Number of Subjects Ablated for Nonsustained Arrhythmias Who Had a Reduction to Less Than 5000 Arrhythmia Beats Daily | 6 months | Number of subjects who had ablation for nonsustained arrhythmias with ventricular dysfunction who had a decrease in ambient ventricular arrhythmia to \< 5000 ventricular beats daily. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Acute Abolition of at Least One Clinical Inducible Ventricular Tachycardia or Targeted Nonsustained Arrhythmia | Baseline to end of the ablation procedure (approximately 5 hours) | Defined as termination of at least one clinical or presumptive clinical monomorphic VT by Radiofrequency ablation and/or rendering that VT no longer inducible or abolition of a targeted nonsustained arrhythmia. |
Countries
United States
Participant flow
Recruitment details
Patients referred for ablation of ventricular arrhythmias who met the entry criteria were enrolled at Vanderbilt University Medical Center or Brigham and Women's Hospital from 9/19/2016 to 8/26/2020.
Pre-assignment details
115 unique subjects signed consent and were enrolled; 6 were consented twice (121 enrollments): 1 had no needle ablation when standard ablation was successful at both procedures; 3 had needle ablation at the first but not the second procedure; 2 had needle ablation twice and outcomes are reported for their first procedure only. Of the 115, 39 exited before treatment (standard ablation successful in 30, VT not inducible in 7, other reasons in 2). Thus, 76 unique participants started the study.
Participants by arm
| Arm | Count |
|---|---|
| Intramural Needle Catheter Ablation Patients Treated With Intramural Needle Ablation | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Intramural Needle Catheter Ablation | — |
|---|---|---|
| Ablation for premature ventricular contractions (PVCs)/Nonsustained VT | 20 Participants | — |
| Ablation for ventricular tachycardia (VT) | 56 Participants | — |
| Age, Continuous | 65 years | — |
| Coronary Artery Disease | 35 Participants | — |
| Failed amiodarone | 61 Participants | — |
| Failed mexiletine | 36 Participants | — |
| History of heart failure | 41 Participants | — |
| Implanted Defibrillator | 60 Participants | — |
| Left Ventricular Ejection Fraction (LVEF) | 0.38 ejection fraction | — |
| Nonischemic heart diseases | 59 Participants | — |
| Number of prior failed ablation procedures (median, range) | 2 prior procedures | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 76 participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 64 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 76 |
| other Total, other adverse events | 5 / 76 |
| serious Total, serious adverse events | 13 / 76 |
Outcome results
Primary
Number of Participants With No Serious Adverse Events
Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intramural Needle Catheter Ablation | Number of Participants With No Serious Adverse Events | 63 Participants |
Primary
Number of Subjects Ablated for Nonsustained Arrhythmias Who Had a Reduction to Less Than 5000 Arrhythmia Beats Daily
Number of subjects who had ablation for nonsustained arrhythmias with ventricular dysfunction who had a decrease in ambient ventricular arrhythmia to \< 5000 ventricular beats daily.
Time frame: 6 months
Population: This outcome is analyzed only for the 20 patients in whom PVCs/Nonsustained VT was the targeted arrhythmia for study entry.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intramural Needle Catheter Ablation | Number of Subjects Ablated for Nonsustained Arrhythmias Who Had a Reduction to Less Than 5000 Arrhythmia Beats Daily | 12 Participants |
Primary
Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months
Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation for VT.
Time frame: 6 months
Population: This outcome is analyzed only for the 54 patients whose targeted arrhythmia was ventricular tachycardia.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intramural Needle Catheter Ablation | Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months | 38 Participants |
Secondary
Number of Subjects With Acute Abolition of at Least One Clinical Inducible Ventricular Tachycardia or Targeted Nonsustained Arrhythmia
Defined as termination of at least one clinical or presumptive clinical monomorphic VT by Radiofrequency ablation and/or rendering that VT no longer inducible or abolition of a targeted nonsustained arrhythmia.
Time frame: Baseline to end of the ablation procedure (approximately 5 hours)
Population: This secondary efficacy endpoint was not assessed in 16 patients in whom VT induction was not attempted because in the judgment of the investigator it imposed unwarranted risk of hemodynamic deterioration. Acute success for PVC/nonsustained VT ablation was abolishing the targeted PVC..
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intramural Needle Catheter Ablation | Number of Subjects With Acute Abolition of at Least One Clinical Inducible Ventricular Tachycardia or Targeted Nonsustained Arrhythmia | 51 Participants |