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出境医 / 临床实验 / VIVO Mapping Protocol

VIVO Mapping Protocol

Study Description
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


Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Ventricular Ectopic Beat(S) Diagnostic Test: VIVO non invasive mapping Not Applicable

Detailed Description:

VIVO TM is a non invasive mapping system which can be used to localize PVC / VT origin prior to the ablative procedure.

Subjects scheduled for catheter ablation with VIVO will undergo a CT scan prior to the procedure, which will be used to create a personalized 3D model. This will be merged with a 3D photograph (taken at the start of the procedure) of the ECG electrodes on the subject's torso.

Then, the recording of the 12 lead ECG will be imported into the VIVO software. All of this data will be combined via the software and a mathematical algorithm will determine the origin of the arrhythmia. This will show the physician where to perform a successful ablation. After 3 months, the subject will return for follow up and will receive another ECG Holter monitor (ECG recording) to determine ablation success.

Subjects will be exited from the study after the 3 month follow up visit. Patients will receive standard clinical care prior to, during and after their scheduled procedure, as well as after being discarded from the trial.

Results will be analysed and compared to those from an historical cohort of patients (age / gender matched, undergone the same procedure) ablated by the same operator within the previous 5 years (from a database already collected). Data will be anonymised as per current regulations.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: VIVO Non-invasive Time Assessment Protocol
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : May 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: VIVO mapping pre-procedure
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
non invasive pre-procedural localization of PVC / VT origin
Outcome Measures
Primary Outcome Measures :
  1. Reduction of procedural time (in minutes) [ Time Frame: three months ]
    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".

  2. Safety - absence of acute adverse events using VIVO system for non-invasive mapping [ Time Frame: three months ]
    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.

  3. Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure [ Time Frame: three months ]
    Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).


Secondary Outcome Measures :
  1. economical outcome: change of procedural costs [ Time Frame: three months ]
    To assess economical outcome, which is meant as cost change (in pounds) per number of cases

  2. clinical outcome assessed as change of PVCs/VT burden [ Time Frame: three months ]
    Count of PVC/VT burden at 3-month follow up Holter (expressed as No. / 24 hours)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Reversible causes of PVC/VT
  2. Subjects with recent (within 3 months) acute coronary syndrome
  3. Subjects who are contraindicated for CT or MRI (must be able to get one)
  4. Subject whose MRI or CT scan does not comply with the requirements of this protocol

  5. 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.
  6. Existing mechanical heart valve
  7. Subjects with structural cardiac disease
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sabine Ernst, MD, PhD 00442073518612 s.ernst@rbht.nhs.uk
Contact: Ilaria Cazzoli, MD I.Cazzoli@rbht.nhs.uk

Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Sabine Ernst, MD, PhD Royal Brompton and Harefield Hospital Trust
Study Chair: Ilaria Cazzoli, MD Royal Brompton and Harefield Hospital Trust
Tracking Information
First Submitted Date  ICMJE May 4, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date June 21, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Reduction of procedural time (in minutes) [ Time Frame: three months ]
    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".
  • Safety - absence of acute adverse events using VIVO system for non-invasive mapping [ Time Frame: three months ]
    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.
  • Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure [ Time Frame: three months ]
    Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • economical outcome: change of procedural costs [ Time Frame: three months ]
    To assess economical outcome, which is meant as cost change (in pounds) per number of cases
  • clinical outcome assessed as change of PVCs/VT burden [ Time Frame: three months ]
    Count of PVC/VT burden at 3-month follow up Holter (expressed as No. / 24 hours)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VIVO Mapping Protocol
Official Title  ICMJE VIVO Non-invasive Time Assessment Protocol
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
Detailed Description

VIVO TM is a non invasive mapping system which can be used to localize PVC / VT origin prior to the ablative procedure.

Subjects scheduled for catheter ablation with VIVO will undergo a CT scan prior to the procedure, which will be used to create a personalized 3D model. This will be merged with a 3D photograph (taken at the start of the procedure) of the ECG electrodes on the subject's torso.

Then, the recording of the 12 lead ECG will be imported into the VIVO software. All of this data will be combined via the software and a mathematical algorithm will determine the origin of the arrhythmia. This will show the physician where to perform a successful ablation. After 3 months, the subject will return for follow up and will receive another ECG Holter monitor (ECG recording) to determine ablation success.

Subjects will be exited from the study after the 3 month follow up visit. Patients will receive standard clinical care prior to, during and after their scheduled procedure, as well as after being discarded from the trial.

Results will be analysed and compared to those from an historical cohort of patients (age / gender matched, undergone the same procedure) ablated by the same operator within the previous 5 years (from a database already collected). Data will be anonymised as per current regulations.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Ventricular Tachycardia
  • Ventricular Ectopic Beat(S)
Intervention  ICMJE Diagnostic Test: VIVO non invasive mapping
non invasive pre-procedural localization of PVC / VT origin
Study Arms  ICMJE Experimental: VIVO mapping pre-procedure
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.
Intervention: Diagnostic Test: VIVO non invasive mapping
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Reversible causes of PVC/VT
  2. Subjects with recent (within 3 months) acute coronary syndrome
  3. Subjects who are contraindicated for CT or MRI (must be able to get one)
  4. Subject whose MRI or CT scan does not comply with the requirements of this protocol

  5. 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.
  6. Existing mechanical heart valve
  7. Subjects with structural cardiac disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994068
Other Study ID Numbers  ICMJE VIVO-RBH01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor  ICMJE Royal Brompton & Harefield NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sabine Ernst, MD, PhD Royal Brompton and Harefield Hospital Trust
Study Chair: Ilaria Cazzoli, MD Royal Brompton and Harefield Hospital Trust
PRS Account Royal Brompton & Harefield NHS Foundation Trust
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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