Premature Ventricular Contraction, Ventricular Arrythmia, Ventricular Tachycardia
Conditions
Brief summary
A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.
Interventions
DEVICEVIVO
VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia.
Sponsors
Catheter Precision. Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must at least 18 years of age Patients who have signed an IRB/EC approved patient informed consent and applicable patient privacy protection authorization per local law * Patients who have previously had contrast cardiac imaging or will have cardiac imaging ordered per standard of care * Patients will be selected without regard to gender.
Exclusion criteria
• Patients that are unable to receive contrast cardiac imaging (MR or CT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the effectiveness of VIVO within different types of VA procedures | 1 day | The primary effectiveness objective is to assess the types of procedures where VIVO is used to plan and/or guide the ablation procedure or to determine a diagnosis of arrhythmia. Primary Effectiveness endpoint: Summarize the types of procedures where VIVO was utilized in the procedure to include the number of VT vs PVC, whether VIVO improved procedural planning and acute procedural success measured as termination or reduction in arrhythmia. |
| Measure the safety by observing adverse events related to the device and procedure | 1 day | Primary safety objective is to assess any adverse events related to the device and procedure. Primary Safety endpoint: Summarize the number of adverse events related to VIVO or procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 12 months | Secondary effectiveness objective is to evaluate the success of the ablation procedure (if performed) at follow- up visits (3, 6 and 12 months). Secondary effectiveness endpoint: Summarize the success of the ablation procedure at each follow up visit. |
Countries
Ireland, Italy, Netherlands, Portugal, United Kingdom
Outcome results
None listed