Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicroPort CRM
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Use of LINEA cardiac pacing lead
DeviceUse of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: LINEA cardiac pacing leadExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 implantation2
LINEA lead pacing threshold amplitude at 3 months
Mean ventricular pacing threshold amplitude
Time frame
3 months after implantationSecondary outcomes
1
Success rate of LINEA lead minimum sensed amplitude
Proportion of patients with minimum sensed amplitude ≥ 5 mV
Time frame
3 months after implantation2
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 implantation3
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 implantation4
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 implantationOther outcomes
1
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 implantation2
Early outcome - LINEA lead pacing threshold amplitude at 1 month
Mean ventricular pacing threshold amplitude
Time frame
1 month after implantation3
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 implantation4
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 implantationSponsors and contacts
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Source ClinicalTrials.gov