Clinical trial NCT06453850: Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
Official title: Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bradycardia
Cardiac Resynchronization Therapy
Left Bundle Branch Area Pacing
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.


Eligibility criteria: Inclusion criteria (phase I):

* 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
* Patient reviewed, signed and dated the Informed Consent Form (ICF)

Inclusion criteria (phase II):

* Patient indicated for cardiac pacing or CRT according to the most recent guidelines from the ESC
* Patient planned for a de novo implantation of any SR or DR CE marked pacemaker, or any CE marked CRT-D
* 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
* Patient reviewed, signed and dated the ICF

Exclusion criteria (phase I):

* 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%
* 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 implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, 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)
* 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

Exclusion criteria (phase II):

* 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 already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
* Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, 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)
* 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

Primary outcomes:
measure: Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
timeFrame: 72 hours after implantation
Secondary outcomes:
measure: Implantation success rates
timeFrame: During implantation
measure: Implantation time
timeFrame: During implantation
measure: Implantation usability
timeFrame: During implantation
measure: Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter
timeFrame: 72 hours after implantation
measure: Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model
timeFrame: During implantation
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: ULS de Coimbra
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
References: