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NCT Number: NCT02799693

Intramural Needle Ablation for Ventricular Tachycardia

This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Following ablation, patients will be monitored for 6 months. The duration of the study is up to 4 years.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

About this study

This is an observational prospective cohort study of patients undergoing needle catheter ablation. Patients with recurrent sustained or incessant ventricular tachycardia who have recurrent monomorphic ventricular tachycardia that has failed antiarrhythmic drug therapy and prior catheter ablation who are undergoing intramural needle ablation for VT will be offered participation. Data will be collected during the procedure and during follow-up. Patients will be monitored in hospital for complications and during 6 months follow-up.

Data Collection:

Baseline Data: Baseline demographic information and a narrative medical history will be collected on all patients, including documentation of prior cardiac history, and arrhythmia history, as well as prior medications and cardiac procedures.

Procedural data: Details of the procedure including both procedural methods and arrhythmias induced, ablation parameters, needle deployments, recordings and response to procedure.

Followup data: Adverse events will be collected for events which are documented during enrollment and follow-up. During follow-up, hospitalizations will be collected, need for further procedures, implantable defibrillator therapies and procedures will be collected, as well as follow-up echocardiography findings.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.

Exclusion criteria

  • Patient refusal to participate

Treatment and study plan

Primary outcomes

  1. Freedom from hospitalization for recurrent VT during 6 months following ablation

    Time frame: 6 months

    Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation

  2. Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure

    Time frame: 6 months

    Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.

Secondary outcomes

  1. Acute Procedural Success

    Time frame: 6 hours

    Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible

  2. Acute procedural complications

    Time frame: 24 hours

    Any complications occurring within 24 hours post procedure described as probably or possibly related to the VT catheter ablation procedure

  3. Number of inducible VT morphologies

    Time frame: 6 hours

    Number of VT morphologies induced during catheter ablation

  4. ICD therapy - shocks

    Time frame: 3 months

    Number of VT events treated with appropriate ICD shocks at 3 months post procedure

  5. ICD therapy - shocks

    Time frame: 6 months

    Number of VT events treated with appropriate ICD shocks at 6 months post procedure

  6. ICD therapy - ATP

    Time frame: 3 months

    Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure

  7. ICD therapy - ATP

    Time frame: 6 months

    Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure

  8. ICD Therapy

    Time frame: 3 months

    Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure

  9. ICD Therapy

    Time frame: 6 months

    Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure

  10. VT storm

    Time frame: 3 months

    Number of VT storm events during 3 months follow-up

  11. VT storm

    Time frame: 6 months

    Number of VT storm events during 6 months follow-up

  12. VT events

    Time frame: 3 months

    Difference in number of VT events during 3 months prior to and following procedure

  13. VT events

    Time frame: 6 months

    Difference in number of VT events during 6 months prior to and following procedure

  14. Recurrent VT

    Time frame: 6 months

    Time to first recurrent VT

  15. Appropriate ATP

    Time frame: 6 months

    Time to first appropriate ATP

  16. Appropriate ICD shock

    Time frame: 6 months

    Time to first appropriate ICD shock

  17. VT Storm

    Time frame: 6 months

    Time to first VT storm

  18. Antiarrhythmic Drug Therapy

    Time frame: 6 months

    Changes in antiarrhythmic drug therapy post-procedure

  19. Total appropriate ICD shocks

    Time frame: 3 months

    Total number of appropriate ICD shocks during 3 months follow up

  20. Total appropriate ICD shocks

    Time frame: 6 months

    Total number of appropriate ICD shocks during 6 months follow up

Sponsors and collaborators

Lead sponsor

John Sapp

Other

Registry information

Official study title

Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2016
Registry last updated
Mar 15, 2022

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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