Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

NCT01791543 | Completed Results DMC FDA Device

• 1 other identifier: 2013P000304
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventricular Tachycardia

Keywords

ventricular tachycardia; ablation; ventricular arrhythmia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• 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)

Study Arms (1)

Intramural Needle Catheter Ablation

EXPERIMENTAL

Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter

Device: Intramural Needle Ablation Catheter

Interventions

Intramural Needle Ablation Catheter DEVICE

Intramural Needle Catheter Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Stevenson: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Related Publications (7)

• 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.

  PMID: 16836718 BACKGROUND

• 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.

  PMID: 24036605 BACKGROUND

• 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.

  PMID: 31604127 BACKGROUND

• 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.

  PMID: 30922472 RESULT

• Tedrow UB, Kurata M, Kawamura I, Batnyam U, Dukkipati S, Nakamura T, Tanigawa S, Fuji A, Richardson TD, Kanagasundram AN, Koruth JS, John RM, Hasegawa K, Abdelwahab A, Sapp J, Reddy VY, Stevenson WG. Worldwide Experience With an Irrigated Needle Catheter for Ablation of Refractory Ventricular Arrhythmias: Final Report. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1475-1486. doi: 10.1016/j.jacep.2023.05.014. Epub 2023 May 19.

  PMID: 37278684 DERIVED

• 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.

  PMID: 35476455 DERIVED

• 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.

  PMID: 32703556 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: William G Stevenson, MD
• Organization: Vanderbilt University Medical Center

william.g.stevenson@vumc.org

1-615-322-2318

Study Officials

• William G. Stevenson, M.D.

  Vanderbilt Heart and Vascular Institute

  STUDY DIRECTOR

• Usha Tedrow, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Cardiovascular Medicine

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 15, 2013
• Study Start: September 1, 2016
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: February 1, 2023
• Results First Posted: February 1, 2023

Record last verified: 2023-01

Locations

US (2)