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

NCT06453850 | Recruiting

• 1 other identifier: DARI01 - POLARIS
• Study Type: interventional
• Target: 216
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Bradycardia; Cardiac Resynchronization Therapy; Left Bundle Branch Area Pacing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Implantation success rates

  During implantation

• Implantation time

  During implantation

• Implantation usability

  During implantation

• Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter

  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

  During implantation

Study Arms (1)

FLEXIGO delivery catheter

EXPERIMENTAL

Device: Use of FLEXIGO delivery catheter

Interventions

Use of FLEXIGO delivery catheter DEVICE

Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead

FLEXIGO delivery catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (3)

ULS de Coimbra

Coimbra, Portugal

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antoine Guihard

CONTACT

+33 1 46 01 33 20; antoine.guihard@crm.microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 12, 2024
• Study Start: February 14, 2025
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); PT (1)