Clinical trial NCT02799693: Intramural Needle Ablation for Ventricular Tachycardia
Official title: Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Ventricular Tachycardia
Keywords: Catheter Ablation
Ventricular Tachycardia
Intramural Needle Catheter
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patient refusal to participate

Primary outcomes:
measure: Freedom from hospitalization for recurrent VT during 6 months following ablation
timeFrame: 6 months
measure: Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure
timeFrame: 6 months
Secondary outcomes:
measure: Acute Procedural Success
timeFrame: 6 hours
measure: Acute procedural complications
timeFrame: 24 hours
measure: Number of inducible VT morphologies
timeFrame: 6 hours
measure: ICD therapy - shocks
timeFrame: 3 months
measure: ICD therapy - shocks
timeFrame: 6 months
measure: ICD therapy - ATP
timeFrame: 3 months
measure: ICD therapy - ATP
timeFrame: 6 months
measure: ICD Therapy
timeFrame: 3 months
measure: ICD Therapy
timeFrame: 6 months
measure: VT storm
timeFrame: 3 months
measure: VT storm
timeFrame: 6 months
measure: VT events
timeFrame: 3 months
measure: VT events
timeFrame: 6 months
measure: Recurrent VT
timeFrame: 6 months
measure: Appropriate ATP
timeFrame: 6 months
measure: Appropriate ICD shock
timeFrame: 6 months
measure: VT Storm
timeFrame: 6 months
measure: Antiarrhythmic Drug Therapy
timeFrame: 6 months
measure: Total appropriate ICD shocks
timeFrame: 3 months
measure: Total appropriate ICD shocks
timeFrame: 6 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: John Sapp, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: