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

Обзор

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

Вмешательства

• Устройство Use of FLEXIGO delivery catheter
  Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead

Первичные конечные точки

• Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter [Срок оценки: 72 hours after implantation]

Вторичные конечные точки (5)

• Implantation success rates [Срок оценки: During implantation]
• Implantation time [Срок оценки: During implantation]
• Implantation usability [Срок оценки: During implantation]
• Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter [Срок оценки: 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 [Срок оценки: During implantation]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Hospital Universitario Virgen de las Nieves — Granada
• Hospital Universitari i Politècnic La Fe — Valencia

Португалия · 1 центр

• ULS de Coimbra — Coimbra

Идентификаторы

NCT: NCT06453850 · DARI01 - POLARIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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