Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum (POLARIS)

MicroPort

Status

Enrolling

Conditions

Bradycardia

Left Bundle Branch Area Pacing

Cardiac Resynchronization Therapy

Treatments

Device: Use of FLEXIGO delivery catheter

Study type

Interventional

Funder types

Industry

Identifiers

DARI01 - POLARIS

Details and patient eligibility

About

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

Enrollment

216 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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