NCT06453850招募中不适用
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
MicroPort CRM3 个研究点 分布在 2 个国家目标入组 216 人开始时间: 2025年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
研究概览
简要总结
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
时间窗: 72 hours after implantation
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.
次要结局
- Implantation usability(During implantation)
- Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter(72 hours after implantation)
- Implantation time(During implantation)
- Implantation success rates(During implantation)
- Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model(During implantation)
研究者
研究点 (3)
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