Evaluating a new catheter for heart pacing lead implantation
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
This study is testing a new catheter to see if it makes it easier and safer for patients needing heart pacing to have their leads implanted.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MicroPort CRM Industry-sponsored |
| Locations | 3 sites (Coimbra and 2 other locations) |
| Trial ID | NCT06453850 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the safety and performance of the FLEXIGO delivery catheter designed for transvenous pacing lead implantation in the interventricular septum. Patients who require cardiac pacing, including those with bradycardia or needing cardiac resynchronization therapy, will be enrolled to evaluate the catheter's effectiveness in these procedures. The study will involve both single and dual chamber pacemaker implantations, ensuring that the catheter is compatible with CE marked ventricular pacing leads. The investigation will follow strict inclusion criteria based on the latest European Society of Cardiology guidelines.
Who should consider this trial
Good fit: Ideal candidates include patients indicated for cardiac pacing or cardiac resynchronization therapy who are undergoing de novo implantation of a pacemaker or CRT device.
Not a fit: Patients who do not require cardiac pacing or are not candidates for catheter-guided implantation in the interventricular septum may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of cardiac pacing procedures for patients with bradycardia and related conditions.
How similar studies have performed: While this approach is innovative, similar studies evaluating catheter technologies for cardiac pacing have shown promising results.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Coimbra and 2 other locations
- ULS de Coimbra — Coimbra, Portugal (Recruiting)
- Hospital Universitario Virgen de las Nieves — Granada, Spain (Recruiting)
- Hospital Universitari i Politècnic La Fe — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Antoine Guihard
- Email: antoine.guihard@crm.microport.com
- Phone: +33 1 46 01 33 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.