VIVO European Observational Registry

July 27, 2021 updated by: Catheter Precision. Inc.

VIVO in a Practical Clinical Experience

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients experiencing ventricular tachycardia (VT) or premature ventricular contractions (PVC) and being considered for or have a scheduled a ventricular ablation procedure.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VIVO
Patients in which VIVO is used.
Device: VIVO
VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 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.
1 day
Safety
Time Frame: 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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catheter Precision. Inc.

Investigators

  • Principal Investigator: Andre Ng, MD, Glenfield University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-0521-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

NO IPD is to be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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