Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Efficacy & Safety
研究概览
简要总结
This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.
详细描述
This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. This study is designed to compare the safety and effectiveness of two types of pacemaker treatments: leadless pacemakers and left bundle area pacing. Patients who's heart rhythm indicate a degree of heart block that slows the heart beat and decreases the amount of blood the heart is pumping to the rest of the body will be identified by physicians to participate. This study seeks to improve our understanding of heart rhythm disorders to allow us to provide the best treatment for our patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical Events Committee is masked
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
- •Planned for:
- •permanent pacemaker implantation for AV node disease (first, second or third degree), OR
- •post-TAVR patient requiring permanent pacemaker implantation
- •Preserved ejection fraction > 50%
- •Preserved sinus node function
- •Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
- •Life expectancy > 1 year
- •Female subject of childbearing potential is not pregnant, not breast feeding, does not plan to be pregnant during the course of the study, and agrees to use a highly effective contraceptive method (i.e. IUD, birth control, vasectomized partner, sexual abstinence, etc.) during the course of the study.
- •Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB
排除标准
- •Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation
- •Anatomical restriction for either MICRA or transvenous pacing such as
- •Access vein occlusion or thrombosis
- •previous radiation therapy at insertion site
- •inferior vena cava filter
- •Endstage renal disease (ESRD)/on dialysis
- •Dementia (inability to give consent)
- •Moderate to Severe or Severe Tricuspid valve regurgitation
- •Moderate to Severe or Severe Mitral valve regurgitation
- •History of mitral or tricuspid valve surgery
- •Preexisting implanted pacemaker or ICD or lead
- •Subject is allergic to titanium
- •Life expectancy < 1 year
- •Recurrent or high risk of infections
- •Active malignancy requiring systemic chemotherapy or local chest radiation
- •Subject has myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit
- •CABG, valve surgery or PCI within the last 3 months except TAVR
- •Other major cardiac surgery within the last 6 months
- •Persistent and permanent atrial fibrillation diagnosed by a healthcare provider
- •NYHA class 3 or 4 Heart Failure
- •Additional post-TAVR Exclusion Criteria:
- •Evidence of renal injury (12 hours post-TAVR)
- •Access site complication(s) post-TAVR
- •Suspicion of stroke/cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 hours post-TAVR
- •Physician suspicion that ambulation to pre-TAVR activities post-pacemaker implantation would be unattainable
- •Other post-TAVR complications that in the opinion of the investigator may seriously confound study outcomes
结局指标
主要结局
Efficacy & Safety
时间窗: 12 months
The composite of: 1. procedural success 2. freedom from serious device-related complications at one year 3. freedom from heart failure or drop in ejection fraction below 50%.
次要结局
- Procedure time(from procedure start to procedure end)
- Device longevity(at 12 month follow up)
研究者
Dinesh Sharma
MD
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH