Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum

Bradycardia Clinical Trial

— POLARIS  

Official title:

Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453850
• Other study ID #: DARI01 - POLARIS
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: MicroPort CRM
• Contact: Antoine Guihard
• Phone: +33 1 46 01 33 20
• Email: antoine.guihard[@]crm.microport.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Cardiac Resynchronization Therapy
• Left Bundle Branch Area Pacing

Intervention

Device:
• Use of FLEXIGO delivery catheter
Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence 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.	72 hours after implantation
Secondary	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.	During implantation
Secondary	Implantation time	Total procedural time and total fluoroscopic time documented per type of cardiac device implanted and per model of catheter used.	During implantation
Secondary	Implantation usability	Implantation usability of the FLEXIGO delivery catheter documented through handling scores based on a specific questionnaire addressed to the operator after implantation.	During implantation
Secondary	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.	72 hours after implantation
Secondary	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.	During implantation