BradycardiaSTARLIGHTNCT07342608
Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
A study testing Use of LINEA cardiac pacing lead in people with Bradycardia and Left Bundle Branch Area Pacing, run by MicroPort CRM at 14 sites in 5 countries.
Trial summary
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- What is being tested?
- Use of LINEA cardiac pacing lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 23 Jun 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)
- Patient planned for a de novo implantation of an ALIZEA, BOREA or CELEA Single Chamber (SR) or Dual Chamber (DR) pacemaker from MicroPort CRM
- Patient planned for a catheter-guided ventricular pacing lead implantation in the interventricular septum area
- Patient's pacemaker with the remote monitoring functions accepted by the patient and planned to be activated
Who cannot join
- Patient planned for a device upgrade, or a device or a lead replacement
- Patient with a congenital heart disease, hypertrophic cardiomyopathy or infiltrative cardiomyopathy
- Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
- Patient having a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient for whom a single dose of steroid eluted by the pacing lead (e.g., dexamethasone sodium phosphate) is contraindicated, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
- Patient with a life expectancy of less than 2 years
Show all 9Show fewer
- Minor age patient (i.e. under 18 years of age)
- Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
- Non-menopausal women
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
France6 sites, 6 recruiting
- Recruiting
Centre Hospitalier Annecy Genevois
Annecy
Pierre Frey, pfrey@ch-annecygenevois.fr
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Pierre-Antoine Catalan, pacatalan@chu-clermontferrand.fr
- Recruiting
CHU Grenoble
Grenoble
Adrien Carabelli, acarabelli@chu-grenoble.fr
- Recruiting
Clinique du Millénaire
Montpellier
Nicolas Clémenty, nicolas.clementy@gmail.com
- Recruiting
CHU Rouen Hôpital Charles Nicolle
Rouen
Raphaël Al Hamoud, raphael.al-hamoud@chu-rouen.fr
- Recruiting
Hôpital Trousseau
Tours
Arnaud Bisson, a.bisson@chu-tours.fr
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona
María Emilce Trucco, metrucco.girona.ics@gencat.cat
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada
Manuel Molina, manuel.molina.lerma@gmail.com
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia
Óscar Cano, oscape13@hotmail.com
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Maggiore della Carità - AO Univ.
Novara
Gabriele Dell'Era, gabriele.dellera@maggioreosp.novara.it
- Recruiting
Ospedale San Cataldo CNR - Fond. Toscana G. Monasterio
Pisa
Gianluca Mirizzi, gmirizzi@ftgm.it
Portugal2 sites, 2 recruiting
- Recruiting
ULS de Coimbra
Coimbra
João Ferreira, joaoaferreira29@gmail.com
- Recruiting
ULS Santa Maria
Lisbon
Nelson Cunha, nelsoncunha@campus.ul.pt
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent
Jan De Pooter, jadpoote.depooter@ugent.be
About this study
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
- Being tested
- Use of LINEA cardiac pacing lead
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of LINEA cardiac pacing leadDevice
Use of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker
| Study group | Role | What they receive |
|---|---|---|
| LINEA cardiac pacing lead | Experimental | Not described Receives: Device: Use of LINEA cardiac pacing lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
LINEA lead complication free rate at 3 months
Proportion of patients free from complication related to the LINEA lead. A complication is defined as a SADE with a probable or causal relationship to the LINEA lead which triggered an additional invasive intervention or resulted in patient death
Measured: 3 months after implantation
LINEA lead pacing threshold amplitude at 3 months
Mean ventricular pacing threshold amplitude
Measured: 3 months after implantation
Secondary outcomes (9)
Success rate of LINEA lead minimum sensed amplitude
Proportion of patients with minimum sensed amplitude ≥ 5 mV
Measured: 3 months after implantation
General performances of LINEA lead
Pacing threshold amplitude, impedance and minimum sensed amplitude obtained with the LINEA lead at each patient's visit. LBB pacing threshold amplitude obtained with the LINEA lead during implantation, as well as the chronaxie measurement
Measured: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
Safety of the LINEA lead
LINEA lead complication free rate over time, calculated based on number of Adverse Events and Device Deficiencies related to the lead
Measured: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
Safety of the FLEXIGO delivery catheter and the FLEXIGO slitter
FLEXIGO catheter complication free rate, calculated based on number of Adverse Events and Device Deficiencies related to the catheter or the slitter
Measured: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
LINEA lead implantation success rates
Proportion of LINEA leads implanted in the interventricular septum and meeting or not LBBAP criteria
Measured: Implantation
Lead and delivery catheter implantation time
Total procedural time and total fluoroscopic time of each implantation
Measured: Implantation
LINEA lead and FLEXIGO delivery catheter and slitter implantation usability
Handling scores based on a specific questionnaire (scale Very poor/Poor/Acceptable/Good/Very good)
Measured: Implantation
Right Ventricular Autothreshold performances
- Accuracy - Comparison between the manual ventricular pacing threshold performed by a physician and the in-clinic ventricular pacing threshold provided by the RVAT function at the same pulse width and during the same on-site patient's visit
Measured: 3 months after implantation
Evolution of LBBAP capture over time
- LBBAP capture evolution with analyses of ECGs (i.e. V6 R-wave peak time and V6-V1 interpeak interval) and LBBAP criteria collected
Measured: 18 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start23 Jun 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342608
- Sponsor's protocol ID
- LLAI01 - STARLIGHT
- Acronym
- STARLIGHT
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
- ClinicalTrials.gov ID
- NCT07342608
- Acronym / sponsor ID
- STARLIGHT / LLAI01 - STARLIGHT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LINEA cardiac pacing lead | Experimental | Device: Use of LINEA cardiac pacing lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)
- Patient planned for a de novo implantation of an ALIZEA, BOREA or CELEA Single Chamber (SR) or Dual Chamber (DR) pacemaker from MicroPort CRM
- Patient planned for a catheter-guided ventricular pacing lead implantation in the interventricular septum area
- Patient's pacemaker with the remote monitoring functions accepted by the patient and planned to be activated
Key exclusion criteria (9 listed)
- Patient planned for a device upgrade, or a device or a lead replacement
- Patient with a congenital heart disease, hypertrophic cardiomyopathy or infiltrative cardiomyopathy
- Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
- Patient having a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient for whom a single dose of steroid eluted by the pacing lead (e.g., dexamethasone sodium phosphate) is contraindicated, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
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 |
|---|---|---|
| Use of LINEA cardiac pacing leadUse of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker | Device | LINEA cardiac pacing lead |
Primary outcome
LINEA lead complication free rate at 3 months
Time frame: 3 months after implantation
Proportion of patients free from complication related to the LINEA lead. A complication is defined as a SADE with a probable or causal relationship to the LINEA lead which triggered an additional invasive intervention or resulted in patient death
LINEA lead pacing threshold amplitude at 3 months
Time frame: 3 months after implantation
Mean ventricular pacing threshold amplitude
9 secondary outcomes
Success rate of LINEA lead minimum sensed amplitude
Time frame: 3 months after implantation
General performances of LINEA lead
Time frame: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
Safety of the LINEA lead
Time frame: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
Safety of the FLEXIGO delivery catheter and the FLEXIGO slitter
Time frame: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
LINEA lead implantation success rates
Time frame: Implantation
Lead and delivery catheter implantation time
Time frame: Implantation
LINEA lead and FLEXIGO delivery catheter and slitter implantation usability
Time frame: Implantation
Right Ventricular Autothreshold performances
Time frame: 3 months after implantation
Evolution of LBBAP capture over time
Time frame: 18 months after implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of LINEA cardiac pacing lead in people with Bradycardia and Left Bundle Branch Area Pacing, run by MicroPort CRM at 14 sites in 5 countries.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Spain, Italy, Portugal, Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Guihard (+33 1 46 01 33 20, antoine.guihard@cf.microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LINEA lead complication free rate at 3 months (time frame: 3 months after implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.