NCT03994068|Unknown
VIVO Mapping Protocol
VIVO Non-invasive Time Assessment Protocol
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VIVO Non-invasive Time Assessment Protocol
Sponsor study identifier
interventional
15
0 countries
N/A
Study Start
June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2019
Actual (reported)June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 21, 2019
Actual (reported)January 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
economical outcome: change of procedural costs
three months
clinical outcome assessed as change of PVCs/VT burden
three months
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.
non invasive pre-procedural localization of PVC / VT origin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sabine Ernst, MD, PhD
Royal Brompton and Harefield Hospital Trust
Ilaria Cazzoli, MD
Royal Brompton and Harefield Hospital Trust
First Submitted
May 4, 2019
First Posted
June 21, 2019
Study Start
June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2020
Estimated (date passed)Stereotactic Non-invasive Ablation of Ventricular Tachycardia
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 21, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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