Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

August 25, 2022 updated by: William Stevenson

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 50%

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intramural Needle Catheter Ablation
Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter
Device: Intramural Needle Ablation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of Ventricular Tachycardia (VT)
Time Frame: 6 months
Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation.
6 months
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
30 days
Reduction of ventricular arrhythmia causing significant ventricular dysfunction
Time Frame: 6 months
decrease in ambient ventricular arrhythmia to < 5000 ventricular beats daily
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Procedural Success
Time Frame: Baseline to end of the ablation procedure (approximately 5 hours)
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.
Baseline to end of the ablation procedure (approximately 5 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Stevenson

Investigators

  • Study Director: William G. Stevenson, M.D., Vanderbilt Heart and Vascular Institute
  • Principal Investigator: Usha Tedrow, M.D., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

May 27, 2022

Study Completion (Actual)

May 27, 2022

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P000304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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