Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791543
• Other study ID #: 2013P000304
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: May 27, 2022

Study information

• Verified date: January 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Intramural Needle Ablation Catheter

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
William Stevenson

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months
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	30 days
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.	6 months
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.	Baseline to end of the ablation procedure (approximately 5 hours)