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.
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
4
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
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
Time frame: 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.
Time frame: 6 months
Acute Procedural Success
Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible
Time frame: 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
Time frame: 24 hours
Number of inducible VT morphologies
Number of VT morphologies induced during catheter ablation
Time frame: 6 hours
ICD therapy - shocks
Number of VT events treated with appropriate ICD shocks at 3 months post procedure
Time frame: 3 months
ICD therapy - shocks
Number of VT events treated with appropriate ICD shocks at 6 months post procedure
Time frame: 6 months
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ICD therapy - ATP
Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure
Time frame: 3 months
ICD therapy - ATP
Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure
Time frame: 6 months
ICD Therapy
Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure
Time frame: 3 months
ICD Therapy
Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure
Time frame: 6 months
VT storm
Number of VT storm events during 3 months follow-up
Time frame: 3 months
VT storm
Number of VT storm events during 6 months follow-up
Time frame: 6 months
VT events
Difference in number of VT events during 3 months prior to and following procedure
Time frame: 3 months
VT events
Difference in number of VT events during 6 months prior to and following procedure
Time frame: 6 months
Recurrent VT
Time to first recurrent VT
Time frame: 6 months
Appropriate ATP
Time to first appropriate ATP
Time frame: 6 months
Appropriate ICD shock
Time to first appropriate ICD shock
Time frame: 6 months
VT Storm
Time to first VT storm
Time frame: 6 months
Antiarrhythmic Drug Therapy
Changes in antiarrhythmic drug therapy post-procedure
Time frame: 6 months
Total appropriate ICD shocks
Total number of appropriate ICD shocks during 3 months follow up
Time frame: 3 months
Total appropriate ICD shocks
Total number of appropriate ICD shocks during 6 months follow up
Time frame: 6 months