VIVO Mapping Protocol

NCT03994068 | Unknown

• 1 other identifier: VIVO-RBH01
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single centre study enrolling 15 subjects with structurally normal hearts that are already indicated for a ventricular ablation procedure (VT or PVCs). The purpose is to compare the accuracy of VIVO and to assess its efficacy to decrease procedural time, and ideally, the procedural overall costs, as compared to standard of care ablation procedures. Results will be compared with data from

Conditions

Ventricular Tachycardia; Ventricular Ectopic Beat(S)

Outcome Measures

Primary Outcomes (3)

• Reduction of procedural time (in minutes)

  Use of VIVO mapping to localize the PVC / VT origin prior to the catheter procedure in order to change procedural time. Procedural time is meant to be measured in minutes per procedure, and it is normally considered from "puncture time" to "sheaths removal".

  three months

• Safety - absence of acute adverse events using VIVO system for non-invasive mapping

  Absence of acute adverse events due to the use of VIVO system during PVC/VT ablation in the cohort of patients enrolled for the study. Acute adverse events are described in section 12 of the study protocol and will be reported in specific forms to the Sponsor and REC.

  three months

• Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure

  Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).

  three months

Secondary Outcomes (2)

• economical outcome: change of procedural costs

  three months

• clinical outcome assessed as change of PVCs/VT burden

  three months

Study Arms (1)

VIVO mapping pre-procedure

EXPERIMENTAL

15 patients with structurally normal heart and indication for PVC/VT catheter ablation, who will undergo pre-procedural non invasive mapping with VIVO mapping system.

Diagnostic Test: VIVO non invasive mapping

Interventions

VIVO non invasive mapping DIAGNOSTIC_TEST

non invasive pre-procedural localization of PVC / VT origin

VIVO mapping pre-procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are at least 18 years or older
• Subjects who are scheduled for PVC/VT ablation procedure
• Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
• Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)
• Subjects with or without cardiac structural disease

You may not qualify if:

• Reversible causes of PVC/VT
• Subjects with recent (within 3 months) acute coronary syndrome
• Subjects who are contraindicated for CT or MRI (must be able to get one)
• Subject whose MRI or CT scan does not comply with the requirements of this protocol
• Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy:
• INR \> 3.5
• Active infection
• Pregnancy: Females of childbearing potential with a positive pregnancy test.
• Existing mechanical heart valve
• Subjects with structural cardiac disease

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature

Study Officials

• Sabine Ernst, MD, PhD

  Royal Brompton and Harefield Hospital Trust

  PRINCIPAL INVESTIGATOR

• Ilaria Cazzoli, MD

  Royal Brompton and Harefield Hospital Trust

  STUDY CHAIR

Central Study Contacts

Sabine Ernst, MD, PhD

CONTACT

00442073518612; s.ernst@rbht.nhs.uk

Ilaria Cazzoli, MD

CONTACT

I.Cazzoli@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: June 21, 2019
• Study Start: June 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: May 31, 2020
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share