Heart Failure
Conditions
Keywords
Heart failure, CRT
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.
Interventions
DEVICEIn-Clinic LVAT
Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.
Sponsors
LivaNova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of SuccessfulIn-Clinic LVAT Test | 0-3 months post inclusion | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Accurate In-Clinic LVAT Test Assessed by an Independent Reviewer | 0-15 days post inclusion | 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 | 0-15 days post inclusion | 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 | 1-3 months after first 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 | 0-3 months post inclusion | Identification of the number of subjects who were eligible to receive the feature at M0 or M1 visit |
| Safety of the LVAT Algorithm | 0-3 months post inclusion | Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm. |
Countries
France
Participant flow
Recruitment details
Subjects have been included from Feb 16, 2017 to June 2, 2017.
Pre-assignment details
All the 60 patients were assigned to the treatment arm.
Participants by arm
| Arm | Count |
|---|---|
| In-Clinic LVAT Single-arm study design: all the 60 patients were assigned to the treatment arm. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | In-Clinic LVAT |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 8.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 60 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment France | 43 participants |
| Region of Enrollment Germany | 8 participants |
| Region of Enrollment Spain | 9 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 44 Participants |
| Type of device implanted IS1 | 24 Participants |
| Type of device implanted IS4 | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 6 / 60 |
Outcome results
Primary
Percentage of SuccessfulIn-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.
Time frame: 0-3 months post inclusion
Population: Complete LV vector test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.~Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered Successful if the difference is within ± 2 step
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-clinic LVAT | Percentage of SuccessfulIn-Clinic LVAT Test | 94.66 percentage of successful LVAT test |
Secondary
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
Time frame: 0-15 days post inclusion
Population: Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.~Accurate LV Vector Test: The LV threshold value provided by the algorithm compared to the reviewer assessment is considered accurate if the difference is within ± 1 step.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-clinic LVAT | Percentage of Accurate In-Clinic LVAT Test Assessed by an Independent Reviewer | 99.31 Percentage of accurate determination |
Secondary
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
Time frame: 0-3 months post inclusion
Population: Eligible subjects: Number of subjects with at least one complete LV Vector Test at M0 or M1 visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-clinic LVAT | Percentage of Eligible Subjects to LVAT Feature | 98.25 Percentage of eligible subjects |
Secondary
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
Time frame: 1-3 months after first visit
Population: Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.~Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered Successful if the difference is within ± 2 steps
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-clinic LVAT | Percentage of Successful In-Clinic LVAT Test at M1 Visit | 92.03 Pecentage of successful LVAT test |
Secondary
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.
Time frame: 0-15 days post inclusion
Population: Completed LV vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.~Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered Successful if the difference is within ± 2 steps
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-clinic LVAT | Percentage of Successful of In-Clinic LVAT Test at M0 Visit | 90.86 Percentage of successful LVAT test |
Secondary
Safety of the LVAT Algorithm
Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.
Time frame: 0-3 months post inclusion
Population: Included population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-clinic LVAT | Safety of the LVAT Algorithm | 6 Event |