Back to resultsClinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA) (LEVEA)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"In-Clinic LVAT"
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, CRT
Eligibility Criteria
Inclusion Criteria:
Subject already implanted (de-novo, upgrade or replacement) according to the relevant ESC Guidelines [1]:
- With IS1 Platinium SonR CRT-D (models 1811, 1841, CE-marked) for maximum of 5 days or;
- With IS4 Platinium SonR CRT-D (model 1844, CE-marked).
- Right atrial, right and left ventricular leads must be implanted. Only bipolar and quadripolar for Left Ventricular lead.
- Reviewed, signed and dated informed consent.
Exclusion Criteria:
- Subject included in another clinical study that could confound the results of this study;
- Malfunction or dislodgment of right atrial, right and left ventricular implanted leads;
- Subject diagnosed with permanent atrial fibrillation;
- Known pregnancy;
- Minor age;
- Under protection or guardianship;
- Unavailability for scheduled follow-up or refusal to cooperate
Sites / Locations
- CHRU Brest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
"In-Clinic LVAT"
Arm Description
All subject prior to study enrollment has been implanted with a CRT-D device. During follow-ups, under the supervision of the physician, the algorithm embeded in the device is activated with a password. The feature is deactivated at the end of each follow-up.
Outcomes
Primary Outcome Measures
Percentage of Successful"In-Clinic LVAT" Test
The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests.
Secondary Outcome Measures
Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer
This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit.
An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations
Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit
The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint.
Percentage of Successful "In-Clinic LVAT" Test at M1 Visit
The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint
Percentage of Eligible Subjects to LVAT Feature
Identification of the number of subjects who were "eligible" to receive the feature at M0 or M1 visit
Safety of the LVAT Algorithm
Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03014180
Brief Title
Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)
Acronym
LEVEA
Official Title
Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
August 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the LEVEA study is to assess the performances of a new automatic left ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by physicians during in-hospital follow-up.
Detailed Description
"In-Clinic LVAT" feature is a non CE-marked feature designed to be activated by the physician during 2 hospital follow-ups:
first visit: planned to be conducted 15 days maximum after inclusion
second visit: planned to be conducted between 1 and 3 months after the first visit The evaluation consists in the comparison between the threshold value provided by the algorithm and the threshold value obtained manually by the physician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, CRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"In-Clinic LVAT"
Arm Type
Experimental
Arm Description
All subject prior to study enrollment has been implanted with a CRT-D device. During follow-ups, under the supervision of the physician, the algorithm embeded in the device is activated with a password. The feature is deactivated at the end of each follow-up.
Intervention Type
Device
Intervention Name(s)
"In-Clinic LVAT"
Other Intervention Name(s)
Activation of an algorithm in CRT-D device
Intervention Description
Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.
Primary Outcome Measure Information:
Title
Percentage of Successful"In-Clinic LVAT" Test
Description
The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests.
Time Frame
0-3 months post inclusion
Secondary Outcome Measure Information:
Title
Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer
Description
This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit.
An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations
Time Frame
0-15 days post inclusion
Title
Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit
Description
The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint.
Time Frame
0-15 days post inclusion
Title
Percentage of Successful "In-Clinic LVAT" Test at M1 Visit
Description
The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint
Time Frame
1-3 months after first visit
Title
Percentage of Eligible Subjects to LVAT Feature
Description
Identification of the number of subjects who were "eligible" to receive the feature at M0 or M1 visit
Time Frame
0-3 months post inclusion
Title
Safety of the LVAT Algorithm
Description
Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.
Time Frame
0-3 months post inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject already implanted (de-novo, upgrade or replacement) according to the relevant ESC Guidelines [1]:
With IS1 Platinium SonR CRT-D (models 1811, 1841, CE-marked) for maximum of 5 days or;
With IS4 Platinium SonR CRT-D (model 1844, CE-marked).
Right atrial, right and left ventricular leads must be implanted. Only bipolar and quadripolar for Left Ventricular lead.
Reviewed, signed and dated informed consent.
Exclusion Criteria:
Subject included in another clinical study that could confound the results of this study;
Malfunction or dislodgment of right atrial, right and left ventricular implanted leads;
Subject diagnosed with permanent atrial fibrillation;
Known pregnancy;
Minor age;
Under protection or guardianship;
Unavailability for scheduled follow-up or refusal to cooperate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Mansourati, Pr
Organizational Affiliation
CHRU de Brest, FRANCE.
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)
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