Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- John Sapp
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.
Exclusion Criteria
- •Patient refusal to participate
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
- Appropriate ICD shock(6 months)
- VT storm(6 months)
- VT events(6 months)
- Recurrent VT(6 months)
- Acute procedural complications(24 hours)
- Acute Procedural Success(6 hours)
- Number of inducible VT morphologies(6 hours)
- ICD therapy - shocks(6 months)
- ICD therapy - ATP(6 months)
- Total appropriate ICD shocks(6 months)
- ICD Therapy(6 months)
- Appropriate ATP(6 months)
- VT Storm(6 months)
- Antiarrhythmic Drug Therapy(6 months)
Investigators
John Sapp
MD FRCPC FRHS
Nova Scotia Health Authority