Intramural Needle Ablation for Ventricular Tachycardia

Completed

• Conditions: Recurrent Ventricular Tachycardia

• Registration Number: NCT02799693
• Lead Sponsor: John Sapp

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Study Start: 2016-07
• Primary Completion: 2018-04-05
• Study Completion: 2018-05-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

Exclusion Criteria

• Patient refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada