Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)

A study testing "In-Clinic LVAT" in people with Heart Failure, run by LivaNova at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: "In-Clinic LVAT"
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteFrance
Study dates: 16 Feb 2017to 17 Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

CHRU Brest
Brest, 29609

Other trials in France

About this study

Official title: Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

Read the 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.

Conditions: Heart Failure
Being tested: "In-Clinic LVAT"
Keywords: Heart failure, CRT
Medical subject headings: Heart Failure, Creatine deficiency, X-linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"In-Clinic LVAT"Device
Also called Activation of an algorithm in CRT-D device
Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.

Study groups in NCT03014180
Study group	Role	What they receive
"In-Clinic LVAT"	Experimental	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. Receives: Device: "In-Clinic LVAT"

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0-3 months post inclusion

Secondary outcomes (5)

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
Measured: 0-15 days post inclusion
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.
Measured: 0-15 days post inclusion
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
Measured: 1-3 months after first visit
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
Measured: 0-3 months post inclusion
Safety of the LVAT Algorithm
Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.
Measured: 0-3 months post inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 201717 Aug 2017

First posted9 Jan 2017 (estimated)
Study start16 Feb 2017
Primary completion17 Aug 2017
Study completion17 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03014180
Sponsor's protocol ID: IPTL01
Acronym: LEVEA
Status last verified: Sep 2018
First submitted: 11 Oct 2016
Last updated: 28 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
CCM OPEN HF Registry
Heart Failure
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm
ClinicalTrials.gov ID: NCT03014180
Acronym / sponsor ID: LEVEA / IPTL01
Conditions: Heart Failure
Keywords: Heart failure, CRT
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: LivaNovaIndustry (pharma, biotech, devices)
Study start: 16 Feb 2017 (actual)
Primary completion: 17 Aug 2017 (actual)
Study completion: 17 Aug 2017 (actual)
First posted: 9 Jan 2017 (estimated)
Results: Posted 28 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
"In-Clinic LVAT"	Experimental	Device: "In-Clinic LVAT"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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject already implanted (de-novo, upgrade or replacement) according to the relevant ESC Guidelines [1]:
Right atrial, right and left ventricular leads must be implanted. Only bipolar and quadripolar for Left Ventricular lead.
Reviewed, signed and dated informed consent.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
"In-Clinic LVAT"Also: Activation of an algorithm in CRT-D deviceAlgorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.	Device	"In-Clinic LVAT"

Primary outcome

Percentage of Successful"In-Clinic LVAT" Test
Time frame: 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.

5 secondary outcomes

Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer
Time frame: 0-15 days post inclusion
Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit
Time frame: 0-15 days post inclusion
Percentage of Successful "In-Clinic LVAT" Test at M1 Visit
Time frame: 1-3 months after first visit
Percentage of Eligible Subjects to LVAT Feature
Time frame: 0-3 months post inclusion
Safety of the LVAT Algorithm
Time frame: 0-3 months post inclusion

Results and safety

Results posted to the registry on 28 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
"In-Clinic LVAT"	60	58

Primary outcome: Percentage of Successful"In-Clinic LVAT" Test

Time frame: 0-3 months post inclusion. Number (95% Confidence Interval). Unit: percentage of successful LVAT test

Measure	In-clinic LVAT n = 56
Value	94.66 (90.66 to 97.31)

Population analysed: 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

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 0-3 months post inclusion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
In-Clinic LVAT	6 of 60 (10%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
CCM OPEN HF Registry
Heart Failure
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacques Mansourati, Pr principal investigator

CHRU de Brest, FRANCE.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing "In-Clinic LVAT" in people with Heart Failure, run by LivaNova at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Successful"In-Clinic LVAT" Test (time frame: 0-3 months post inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03014180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019; AzTrials last refreshed its copy on 28 Oct 2026.