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Completed

NCT Number: NCT01791543

Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

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

Treatment and study plan

Intramural Needle Ablation Catheter

Device

Primary outcomes

  1. Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months

    Time frame: 6 months

    Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation for VT.

  2. Number of Participants With No 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. Number of Subjects Ablated for Nonsustained Arrhythmias Who Had a Reduction to Less Than 5000 Arrhythmia Beats Daily

    Time frame: 6 months

    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.

Secondary outcomes

  1. Number of Subjects With Acute Abolition of at Least One Clinical Inducible Ventricular Tachycardia or Targeted Nonsustained Arrhythmia

    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 or abolition of a targeted nonsustained arrhythmia.

Sponsors and collaborators

Lead sponsor

William Stevenson

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2013
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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