Intramural Needle Ablation for Ventricular Tachycardia

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Ventricular Tachycardia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • QEII Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent ventricular tachycardia who have failed radiofrequency catheter ablation who are undergoing intramural needle catheter ablation procedures.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient refusal to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Recurrent VT failing RF ablation; Patients undergoing intramural needle catheter ablation of recurrent monomorphic ventricular tachycardia who have failed prior attempted radiofrequency catheter ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from hospitalization for recurrent VT during 6 months following ablation	Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation	6 months
Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure	Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Procedural Success	Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible	6 hours
Acute procedural complications	Any complications occurring within 24 hours post procedure described as probably or possibly related to the VT catheter ablation procedure	24 hours
Number of inducible VT morphologies	Number of VT morphologies induced during catheter ablation	6 hours
ICD therapy - shocks	Number of VT events treated with appropriate ICD shocks at 3 months post procedure	3 months
ICD therapy - shocks	Number of VT events treated with appropriate ICD shocks at 6 months post procedure	6 months
ICD therapy - ATP	Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure	3 months
ICD therapy - ATP	Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure	6 months
ICD Therapy	Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure	3 months
ICD Therapy	Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure	6 months
VT storm	Number of VT storm events during 3 months follow-up	3 months
VT storm	Number of VT storm events during 6 months follow-up	6 months
VT events	Difference in number of VT events during 3 months prior to and following procedure	3 months
VT events	Difference in number of VT events during 6 months prior to and following procedure	6 months
Recurrent VT	Time to first recurrent VT	6 months
Appropriate ATP	Time to first appropriate ATP	6 months
Appropriate ICD shock	Time to first appropriate ICD shock	6 months
VT Storm	Time to first VT storm	6 months
Antiarrhythmic Drug Therapy	Changes in antiarrhythmic drug therapy post-procedure	6 months
Total appropriate ICD shocks	Total number of appropriate ICD shocks during 3 months follow up	3 months
Total appropriate ICD shocks	Total number of appropriate ICD shocks during 6 months follow up	6 months

Collaborators and Investigators

• Sponsor: John Sapp

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): April 5, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Catheter Ablation; Ventricular Tachycardia; Intramural Needle Catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: Sapp002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No