QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
NCT Number: NCT03523286
RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Halifax, Nova Scotia, B3H 3A7, Canada
Consecutive patients with ischemic heart disease and clinical indication of VT ablation will undergo baseline clinical evaluation, echocardiography and cardiac CT imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. Trans-axial CT images comprising the whole heart volume will be exported in DICOM format. CT image processing will be performed and will be used to delineate the LV endocardial and/or epicardial geometries. These data will be imported into the RAPID-VT software and the 3D-electranatomical mapping system for image integration.
During the VT ablation procedure, VT(s) induction will be performed. The VT(s) 12-lead ECG will be acquired by the RAPID-VT software and will be localized to the scar margin using the RAPID-VT software. Catheter ablation will be attempted at software-determined sites.
Post procedure, patient will be followed up for a minimum of 6 months. That will include Remote ICD follow-up and telephone study visits. Follow-up at 6 months will include a clinic visit for assessment of heart failure status, ECG, ICD interrogation and changes in antiarrhythmic drug therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD
Exclusion criteria
Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software
Time frame: At end of ablation procedure
Lack of any inducible VT at the end of the ablation procedure
Time frame: At end of procedure
Number of VTs identified and targeted with ablation
Time frame: At end of procedure
Duration of procedure in minutes
Time frame: During follow up period of 6 months
Time to recurrence of VT in months
Time frame: At end of procedure and at 30 days of follow up
Incidence of any procedure-related complications
Time frame: At end of procedure, at 30 days and 6 months of follow up
Worsening of heart failure symptoms as defined as decline in NYHA Functional class or 6-MWT
Time frame: At 30 days and 6 months of follow up
Death and/or cardiac hospitalization
Amir AbdelWahab
Other
Real-time Automated Program for IDentification of VT Origin - Pilot Study
Acronym: RAPIDVTPilot
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03997201
Arrhythmias, Cardiac, Cardiac Conduction System Disease
London, United Kingdom
View Trial DetailsNCT06294028
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Toulouse, France
View Trial DetailsNCT06891456
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Cleveland, Ohio, United States
View Trial DetailsNCT07585968
Arrhythmias, Cardiac, Cardiac Conduction System Disease
Columbus, Ohio, United States
View Trial Details