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Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

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ClinicalTrials.gov Identifier: NCT01791543
Recruitment Status : Recruiting
First Posted : February 15, 2013
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Ventricular Tachycardia Device: Intramural Needle Ablation Catheter

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intramural Needle Catheter Ablation
Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter
Device: Intramural Needle Ablation Catheter


Outcome Measures

Primary Outcome Measures :
  1. Control of Ventricular Tachycardia (VT) [ Time Frame: 6 months ]
    Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation.

  2. Absence of all serious adverse events [ Time Frame: 30 days ]
    Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure

  3. Reduction of ventricular arrhythmia causing significant ventricular dysfunction [ Time Frame: 6 months ]
    decrease in ambient ventricular arrhythmia to < 5000 ventricular beats daily


Secondary Outcome Measures :
  1. Acute Procedural Success [ Time Frame: Absence of inducible clinical VT at then end of the ablation procedure. ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Monomorphic ventricular tachycardia 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 LV ejection fraction to less than 40%

Arrhythmia meet the following criteria:

  1. Ventricular arrhythmia is recurrent and symptomatic
  2. prior antiarrhythmic drug therapy has failed due to recurrent ventricular arrythmia, toxicity, or intolerance

    • Age 18 or older
    • Left ventricular (LV) ejection fraction > 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791543


Contacts
Contact: Christine P. Pellegrini, MSN/MHSA 617-732-5241 cpellegrini@bwh.harvard.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Usha Tedrow, M.D.    857-307-1947    utedrow@bwh.harvard.edu   
Principal Investigator: Usha Tedrow, M.D.         
United States, Tennessee
Vanderbilt Heart and Vascular Institute Recruiting
Nashville, Tennessee, United States, 37232
Contact: William G Stevenson, M.D.    615-936-7537    william.g.stevenson@vanderbilt.edu   
Sub-Investigator: William G Stevenson, M.D.         
Principal Investigator: Roy John, M.D.         
Sponsors and Collaborators
William G. Stevenson, MD
Investigators
Study Director: William G. Stevenson, M.D. Vanderbilt Heart and Vascular Institute
Principal Investigator: Usha Tedrow, M.D. Brigham and Women's Hospital
Principal Investigator: Roy John, M.D. Vanderbilt Heart and Vascular Institute
More Information

Publications:
Responsible Party: William G. Stevenson, MD, Director, Clinical Cardiac Electrophysiology Program, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01791543     History of Changes
Other Study ID Numbers: 2013P000304
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by William G. Stevenson, MD, Brigham and Women's Hospital:
ventricular tachycardia
ablation
ventricular arrhythmia

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes