Left Bundle Branch Area Pacing (LBBAP) PMCF Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- Infection Rate
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
详细描述
The Left Bundle Branch Area Pacing (LBBAP) Post-Market Clinical Follow-up (PMCF) Study is a global, prospective, single-arm, multi-center trial conducted to support an indication expansion of the Tendril STS (model 2088TC) and UltiPace (model LPA1231) leads to include pacing/sensing in the left bundle branch area (LBBA).
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
- •Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area
- •Are ≥ 18 years of age or age of legal consent, whichever age is greater.
- •Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
- •Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.
排除标准
- •Patient meets a standard contraindication for lead implant including:
- •the presence of tricuspid atresia
- •patients with mechanical tricuspid valves
- •patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate
- •Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device
- •Patient has had a previous unsuccessful attempt to place a lead in the LBB area
- •Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
- •Patient is expected to receive a heart transplant within 6 months
- •Patient life expectancy less than 6 months
- •Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
- •Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.
研究组 & 干预措施
Left Bundle Branch Area Pacing Lead Implant
Data will be collected from patients implanted with either the Tendril STS 2088TC or UltiPace LPA1231 lead in the left bundle branch area for pacing and sensing from implant through 6 months. Leads are indicated for use in combination with a compatible pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device.
干预措施: LBBAP lead (Device)
结局指标
主要结局
Infection Rate
时间窗: 0-6 months
Rate of Infection
Impedence
时间窗: 0-6 months
Measure of lead impedance
Perforation Rate
时间窗: 0-6 months
Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.
Malfunction Rate
时间窗: 0-6 months
Malfunction includes 1) mechanical lead failure including lead insulation issues, lead fracture, and other lead damage, dysfunction, helix damage or fracture; malfunction or failure; and 2) electrical abnormalities of unknown cause including sensing issues, pacing issues, loss of capture, impedance abnormality, and noise; 3) excludes infection, perforation or dislodgement caused inappropriate therapy.
Cardiovascular Injury Rate
时间窗: 0-6 months
Cardiovascular Injury is a safety measure specific to LBBAP leads and includes Acute coronary syndrome; Coronary artery fistula; Coronary vein fistula/injury and Septal hematoma. This parameter also includes the right bundle branch block and complete heart block (permanent).
Implant success rate
时间窗: At the time of implant
Rate of Implant success of LBBAP lead
Lead dislodgement rate
时间窗: 0-6 months
Rate of LBBAP lead dislodgement
Pacing threshold
时间窗: 0-6 months
Measure of minimum electrical energy required to stimulate and depolarize
Sensing Amplitude
时间窗: 0-6 months
Measure of lead sensing amplitude
次要结局
未报告次要终点