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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04990089
Other study ID # 02-0521-001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2023

Study information

Verified date July 2021
Source Catheter Precision. Inc.
Contact Missiaen Huck
Phone 973-691-2000
Email mhuck@catheterprecision.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 125
Est. completion date September 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Device:
VIVO
VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Catheter Precision. Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness 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.
1 day
Primary Safety 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.
1 day
Secondary Effectiveness 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.
12 months
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