Intramural Needle Ablation for Ventricular Tachycardia

Recurrent Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799693
• Other study ID #: Sapp002
• Status: Completed
• Start date: July 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: March 2022
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 30, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient refusal to participate

Related Conditions & MeSH terms

• Recurrent Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
John Sapp

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of inducible VT morphologies	Number of VT morphologies induced during catheter ablation	6 hours
Secondary	ICD therapy - shocks	Number of VT events treated with appropriate ICD shocks at 3 months post procedure	3 months
Secondary	ICD therapy - shocks	Number of VT events treated with appropriate ICD shocks at 6 months post procedure	6 months
Secondary	ICD therapy - ATP	Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure	3 months
Secondary	ICD therapy - ATP	Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure	6 months
Secondary	ICD Therapy	Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure	3 months
Secondary	ICD Therapy	Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure	6 months
Secondary	VT storm	Number of VT storm events during 3 months follow-up	3 months
Secondary	VT storm	Number of VT storm events during 6 months follow-up	6 months
Secondary	VT events	Difference in number of VT events during 3 months prior to and following procedure	3 months
Secondary	VT events	Difference in number of VT events during 6 months prior to and following procedure	6 months
Secondary	Recurrent VT	Time to first recurrent VT	6 months
Secondary	Appropriate ATP	Time to first appropriate ATP	6 months
Secondary	Appropriate ICD shock	Time to first appropriate ICD shock	6 months
Secondary	VT Storm	Time to first VT storm	6 months
Secondary	Antiarrhythmic Drug Therapy	Changes in antiarrhythmic drug therapy post-procedure	6 months
Secondary	Total appropriate ICD shocks	Total number of appropriate ICD shocks during 3 months follow up	3 months
Secondary	Total appropriate ICD shocks	Total number of appropriate ICD shocks during 6 months follow up	6 months