The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead
ULS de Coimbra
Coimbra, Portugal
RECRUITINGHospital Universitario Virgen de las Nieves
Granada, Spain
RECRUITINGHospital Universitari i Politècnic La Fe
Valencia, Spain
RECRUITINGAbsence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
Any event caused by use of the FLEXIGO delivery catheter or any accessory packaged with the catheter, will be considered as an ADE related to the FLEXIGO delivery catheter. The primary endpoint evaluation will be based on Sponsor assessment of safety events, based on investigational site reporting.
Time frame: 72 hours after implantation
Implantation success rates
\- Implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter. \- Left Bundle Branch Area Pacing (LBBAP) implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter and fulfilling LBBAP success criteria according to the operator's decision. \- LBBAP implantation success rate (overall): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria.
Time frame: During implantation
Implantation time
Total procedural time and total fluoroscopic time documented per type of cardiac device implanted and per model of catheter used.
Time frame: During implantation
Implantation usability
Implantation usability of the FLEXIGO delivery catheter documented through handling scores based on a specific questionnaire addressed to the operator after implantation.
Time frame: During implantation
Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter
Proportion of SADE related to the FLEXIGO delivery catheter or the slitter.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 72 hours after implantation
Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model
\- LBBAP implantation success rate with FLEXIGO delivery catheter (documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter and fulfilling LBBAP success criteria according to the operator's decision. \- LBBAP implantation success rate (overall, and documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria according to the operator's decision.
Time frame: During implantation