Clinical trial NCT01791543: Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia
Official title: Early Feasibility Study of Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: ventricular tachycardia
ablation
ventricular arrhythmia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months
timeFrame: 6 months
measure: Number of Participants With No Serious Adverse Events
timeFrame: 30 days
measure: Number of Subjects Ablated for Nonsustained Arrhythmias Who Had a Reduction to Less Than 5000 Arrhythmia Beats Daily
timeFrame: 6 months
Secondary outcomes:
measure: Number of Subjects With Acute Abolition of at Least One Clinical Inducible Ventricular Tachycardia or Targeted Nonsustained Arrhythmia
timeFrame: Baseline to end of the ablation procedure (approximately 5 hours)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
Study officials:
affiliation: Vanderbilt Heart and Vascular Institute
name: William G. Stevenson, M.D.
role: STUDY_DIRECTOR
affiliation: Brigham and Women's Hospital
name: Usha Tedrow, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sapp JL, Cooper JM, Zei P, Stevenson WG. Large radiofrequency ablation lesions can be created with a retractable infusion-needle catheter. J Cardiovasc Electrophysiol. 2006 Jun;17(6):657-61. doi: 10.1111/j.1540-8167.2006.00439.x.
citation: Sapp JL, Beeckler C, Pike R, Parkash R, Gray CJ, Zeppenfeld K, Kuriachan V, Stevenson WG. Initial human feasibility of infusion needle catheter ablation for refractory ventricular tachycardia. Circulation. 2013 Nov 19;128(21):2289-95. doi: 10.1161/CIRCULATIONAHA.113.003423. Epub 2013 Sep 13.
citation: Schaeffer B, Tanigawa S, Nakamura T, Muthalaly RG, Sapp J, John R, Ghidoli D, Pellegrini C, Tedrow U, Stevenson WG. Characteristics of myocardial tissue staining and lesion creation with an infusion-needle ablation catheter for the treatment of ventricular tachycardia in humans. Heart Rhythm. 2020 Mar;17(3):398-405. doi: 10.1016/j.hrthm.2019.10.007. Epub 2019 Oct 8.
citation: Stevenson WG, Tedrow UB, Reddy V, AbdelWahab A, Dukkipati S, John RM, Fujii A, Schaeffer B, Tanigawa S, Elsokkari I, Koruth J, Nakamura T, Naniwadekar A, Ghidoli D, Pellegrini C, Sapp JL. Infusion Needle Radiofrequency Ablation for Treatment of Refractory Ventricular Arrhythmias. J Am Coll Cardiol. 2019 Apr 2;73(12):1413-1425. doi: 10.1016/j.jacc.2018.12.070.
citation: Dukkipati SR, Nakamura T, Nakajima I, Oates C, Narui R, Tanigawa S, Sljapic T, Whang W, Koruth JS, Choudry S, Schaeffer B, Fujii A, Tedrow UB, Sapp JL, Stevenson WG, Reddy VY. Intramural Needle Ablation for Refractory Premature Ventricular Contractions. Circ Arrhythm Electrophysiol. 2022 May;15(5):e010020. doi: 10.1161/CIRCEP.121.010020. Epub 2022 Apr 27.
citation: Qian PC, Oberfeld B, Schaeffer B, Nakamura T, John RM, Sapp JL, Stevenson WG, Tedrow UB. Frequency Content of Unipolar Electrograms May Predict Deep Intramural Excitable Substrate: Insights From Intramural Needle Catheter Ablation of Ventricular Tachycardia. JACC Clin Electrophysiol. 2020 Jul;6(7):760-769. doi: 10.1016/j.jacep.2020.03.003. Epub 2020 Apr 29.