An interventional study of Use of LINEA cardiac pacing lead in Bradycardia, Left Bundle Branch Area Pacing and Left Bundle Branch Pacing, sponsored by MicroPort CRM. Recruiting at 14 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by MicroPort CRM (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 450 is above the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →MicroPort CRM is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
First submitted after MicroPort CRM became part of MicroPort Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria (phase I and II):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Use of LINEA cardiac pacing lead
Use of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker
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
Time frame: 3 months after implantation
LINEA lead pacing threshold amplitude at 3 months
Mean ventricular pacing threshold amplitude
Time frame: 3 months after implantation
Success rate of LINEA lead minimum sensed amplitude
Proportion of patients with minimum sensed amplitude ≥ 5 mV
Time frame: 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
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
LINEA lead complication free rate over time, calculated based on number of Adverse Events and Device Deficiencies related to the 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
FLEXIGO catheter complication free rate, calculated based on number of Adverse Events and Device Deficiencies related to the catheter or the 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
Proportion of LINEA leads implanted in the interventricular septum and meeting or not LBBAP criteria
Time frame: Implantation
Lead and delivery catheter implantation time
Total procedural time and total fluoroscopic time of each implantation
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 18 months after implantation
Early outcome - Absence of Unanticipated Serious Adverse Device Effect (USADE) related to LINEA lead
Proportion of patients free from USADE. Any event caused by use of the LINEA lead or any accessory packaged with the lead, will be considered as an ADE related to the LINEA lead. The endpoint evaluation will be based on an independent safety events adjudication from a Clinical Events Committee (CEC), based on investigational site reporting
Time frame: 1 month after implantation
Early outcome - LINEA lead pacing threshold amplitude at 1 month
Mean ventricular pacing threshold amplitude
Time frame: 1 month after implantation
Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance
\- Implantation success rate - Proportion of LINEA lead successfully implanted at the interventricular septum and fulfilling or not LBBAP success criteria according to the operator's decision
Time frame: 1 month after implantation
Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance
\- Short term electrical performances variation - Pacing threshold variation between implantation and 1 month, and electrical performances of the LINEA lead (pacing threshold, impedance and minimum sensed amplitude)
Time frame: 1 month after implantation
Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance
\- Complication free rate - 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
Time frame: 1 month after implantation
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jan 2027, 7 months after the start.
Of 36 industry-sponsored interventional studies with no phase under Bradycardia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's planned 7 months is below that.
Counting every sponsor, half of 83 studies reached it within 21 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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