Intramural Needle Ablation for Ventricular Tachycardia
Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
1 other identifier
observational
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2018
CompletedMarch 15, 2022
March 1, 2022
1.8 years
June 2, 2016
March 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (20)
Acute Procedural Success
6 hours
Acute procedural complications
24 hours
Number of inducible VT morphologies
6 hours
ICD therapy - shocks
3 months
ICD therapy - shocks
6 months
- +15 more secondary outcomes
Study Arms (1)
Recurrent VT failing RF ablation
Patients undergoing intramural needle catheter ablation of recurrent monomorphic ventricular tachycardia who have failed prior attempted radiofrequency catheter ablation.
Eligibility Criteria
Patients with recurrent ventricular tachycardia who have failed radiofrequency catheter ablation who are undergoing intramural needle catheter ablation procedures.
You may qualify if:
- Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.
You may not qualify if:
- Patient refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- John Sapplead
Study Sites (1)
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Sapp, MD FRCPC
Nova Scotia Health Authority
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD FRCPC FRHS
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 15, 2016
Study Start
July 1, 2016
Primary Completion
April 5, 2018
Study Completion
May 30, 2018
Last Updated
March 15, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share