Trials / Completed
CompletedNCT03523286
Real-time Automated Program for IDentification of VT Origin
Real-time Automated Program for IDentification of VT Origin - Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Amir AbdelWahab · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | RAPID-VT Software guided ablation | Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2021-11-01
- Completion
- 2022-05-01
- First posted
- 2018-05-14
- Last updated
- 2023-02-08
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03523286. Inclusion in this directory is not an endorsement.