NCT01700244Unknown不适用
Evaluation of a New Cardiac Pacemaker
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Complication rate, where a complication is defined as a serious adverse device effect (SADE)
研究概览
简要总结
An evaluation of a safety and performance of a new cardiac pacemaker
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
- •Subject must have one of the following clinical indications:
- •Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or
- •Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
- •Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
- •Subject ≥18 years of age;
- •Subject has life expectancy of at least one year;
- •Subject is not enrolled in another clinical investigation;
- •Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;
- •Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC;
- •If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.
排除标准
- •Pacemaker dependent;
- •Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
- •Hypersensitivity to < 1 mg of dexamethasone sodium phosphate;
- •Mechanical tricuspid valve prosthesis;
- •Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease;
- •Pre-existing pacing or defibrillation leads;
- •Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT);
- •Presence of implanted vena cava filter;
- •Presence of implanted leadless cardiac pacemaker;
- •Pregnant or breastfeeding.
研究组 & 干预措施
Pacemaker
Experimental
干预措施: Pacemaker implant (Device)
结局指标
主要结局
Complication rate, where a complication is defined as a serious adverse device effect (SADE)
时间窗: 90 days
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
招募中
不适用
Chronic Evaluation of Novel Pacemaker SystemVentricular Pacing With Rate ResponseBradycardiaNCT06056817Calyan Technologies10
已完成
不适用
Adapta Pacing System Clinical StudyPacemakerBradycardiaNCT00307073Medtronic Cardiac Rhythm and Heart Failure120
已完成
不适用
Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation StudyHeart DiseasesNCT05104307Stephen Esper79
已完成
不适用
Detection of Heart Rhythm and BP With RhythmPadBPAtrial FibrillationNCT03813446Cardiocity Limited1,100
Unknown
2 期
Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.Periodic BreathingNCT01044407Imperial College London14