Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 by Brigham and Women's Hospital
Information provided by (Responsible Party):
William G. Stevenson, MD, Brigham and Women's Hospital Identifier:
First received: February 7, 2013
Last updated: May 17, 2016
Last verified: May 2016

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 tachycardia that has failed standard radiofrequency ablation. This approach is desirable because some people have ventricular tachycardia that originates 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 tachycardia that has failed standard radiofrequency ablation. The investigators also want to determine if it is likely to be safe, without excessive side effects.

Condition Intervention
Ventricular Tachycardia
Device: Intramural Needle Ablation Catheter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Control of Ventricular Tachycardia (VT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation.

  • Absence of all serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure

Secondary Outcome Measures:
  • Acute Procedural Success [ Time Frame: Absence of inducible clinical VT at then end of the ablation procedure. ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 20
Study Start Date: August 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intramural Needle Catheter Ablation
Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter
Device: Intramural Needle Ablation Catheter


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Monomorphic ventricular tachycardia that meets the following criteria:

    1. VT is recurrent and symptomatic
    2. prior antiarrhythmic drug therapy has failed due to recurrent VT, toxicity, or intolerance
  • Age 18 or older
  • Left ventricular (LV) ejection fraction > 10% as estimated by echocardiography,contrast ventriculography or radionuclide imaging within the previous 90 days
  • Failed prior VT ablation due to spontaneous recurrence of sustained VT.
  • 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. Patients with mildly depressed ventricular function that can be attributed entirely to frequent ventricular arrhythmia will be considered as having idiopathic VT.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01791543

Contact: Christine P. Pellegrini, MSN/MHSA 617-732-5241

United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Sub-Investigator: William G. Stevenson, M.D.         
Principal Investigator: Roy John, M.D.         
Sponsors and Collaborators
William G. Stevenson, MD
Study Director: William G. Stevenson, M.D. Brigham and Women's Hospital
Principal Investigator: Roy John, M.D., Ph.D. Brigham and Women's Hospital
  More Information

Responsible Party: William G. Stevenson, MD, Director, Clinical Cardiac Electrophysiology Program, Brigham and Women's Hospital Identifier: NCT01791543     History of Changes
Other Study ID Numbers: 2013P000304 
Study First Received: February 7, 2013
Last Updated: May 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
ventricular tachycardia
ventricular arrhythmia

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on May 30, 2016