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Trial Outcomes & Findings for Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA) (NCT NCT03014180)

NCT ID: NCT03014180

Last Updated: 2019-05-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

0-3 months post inclusion

Results posted on

2019-05-28

Participant Flow

Subjects have been included from Feb 16, 2017 to June 2, 2017.

All the 60 patients were assigned to the treatment arm.

Participant milestones

Participant milestones
Measure
"In-Clinic LVAT"
60 patients were included in the single-arm study. The Left Ventricular auto threshold (LVAT) algorithm test was performed at the 2 study visits M0 and M1.
Overall Study
STARTED
60
Overall Study
COMPLETED
58
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
"In-Clinic LVAT"
60 patients were included in the single-arm study. The Left Ventricular auto threshold (LVAT) algorithm test was performed at the 2 study visits M0 and M1.
Overall Study
Protocol Violation
2

Baseline Characteristics

Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
"In-Clinic LVAT"
n=60 Participants
Single-arm study design: all the 60 patients were assigned to the treatment arm.
Age, Continuous
68.4 years
STANDARD_DEVIATION 8.97 • n=5 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
Sex: Female, Male
Male
44 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
60 Participants
n=5 Participants
Region of Enrollment
France
43 participants
n=5 Participants
Region of Enrollment
Spain
9 participants
n=5 Participants
Region of Enrollment
Germany
8 participants
n=5 Participants
Type of device implanted
IS1
24 Participants
n=5 Participants
Type of device implanted
IS4
36 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
In-clinic LVAT
n=262 Completed LV vector tests
Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.
Percentage of Successful"In-Clinic LVAT" Test
94.66 percentage of successful LVAT test
Interval 90.66 to 97.31

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
In-clinic LVAT
n=1301 Number of completed LV Vector Tests
Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.
Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer
99.31 Percentage of accurate determination
Interval 98.59 to 99.72

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
In-clinic LVAT
n=1193 Number of completed LV Vector Tests
Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.
Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit
90.86 Percentage of successful LVAT test
Interval 88.82 to 92.65

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure
In-clinic LVAT
n=1217 Number of completed LV Vector Tests
Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.
Percentage of Successful "In-Clinic LVAT" Test at M1 Visit
92.03 Pecentage of successful LVAT test
Interval 90.12 to 93.68

SECONDARY outcome

Timeframe: 0-3 months post inclusion

Population: Eligible subjects: Number of subjects with at least one complete LV Vector Test at M0 or M1 visits

Identification of the number of subjects who were "eligible" to receive the feature at M0 or M1 visit

Outcome measures

Outcome measures
Measure
In-clinic LVAT
n=57 Participants
Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.
Percentage of Eligible Subjects to LVAT Feature
98.25 Percentage of eligible subjects

SECONDARY outcome

Timeframe: 0-3 months post inclusion

Population: Included population

Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.

Outcome measures

Outcome measures
Measure
In-clinic LVAT
n=60 Participants
Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.
Safety of the LVAT Algorithm
6 Event

Adverse Events

In-Clinic LVAT

Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
In-Clinic LVAT
n=60 participants at risk
All serious adverse events and device deficiency during in-clinic LVAT test.
Cardiac disorders
Cardiac decompensation
3.3%
2/60 • Number of events 2 • 0-3 months post inclusion
SAE and device deficiency were collected through the study duration and AE was collected at each study visit.
Cardiac disorders
Heart failure worsening
1.7%
1/60 • Number of events 1 • 0-3 months post inclusion
SAE and device deficiency were collected through the study duration and AE was collected at each study visit.
Injury, poisoning and procedural complications
Bleeding
3.3%
2/60 • Number of events 2 • 0-3 months post inclusion
SAE and device deficiency were collected through the study duration and AE was collected at each study visit.
Vascular disorders
Embolization
1.7%
1/60 • Number of events 1 • 0-3 months post inclusion
SAE and device deficiency were collected through the study duration and AE was collected at each study visit.

Other adverse events

Adverse event data not reported

Additional Information

Director of Scientific Communication

Microport CRM

Phone: 0677164209

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60