Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At 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 of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Eligibility criteria
Qualifiers
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 any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker
Patient planned for a catheter-guided implantation in the interventricular septum area
Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter
Disqualifiers
Patient planned for a device upgrade, or a device or a lead replacement
Patient with a congenital heart disease
Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy
Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
Trial design
Treatments tested in this trial
- Use of FLEXIGO delivery catheter
Treatment groups
216 Participants
are divided into 1 treatment groupLocations
3Portugal
ULS de Coimbra Coimbra Portugal
Spain
Hospital Universitario Virgen de las Nieves Granada Spain
Hospital Universitari i Politècnic La Fe Valencia Spain
Sponsors and collaborators
MicroPort CRM
Lead sponsor
Source ClinicalTrials.gov