NCT00746135已完成不适用
TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement according to Packer's "Heart Failure Clinical Composite Respond"
研究概览
简要总结
It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac resynchronization therapy (CRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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 with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure
- •LVEDD > 55 mm or > 30 mm/m² BSA
- •EF < 35%
- •Sinus rhythm and one of the following criteria:
- •QRS >= 120 ms and PQ >= 200ms
- •2nd / 3rd degree AV block
- •Written informed consent
排除标准
- •pacemaker indication (without ICD indication)
- •tricuspidal valve and/or aortic valve replacement
- •Indication for revascularization.
- •less than 3 month after heart surgery or myocardial infarction
- •hypertrophic obstructive cardiomyopathy
- •intravenous catecholamine treatment
- •uncorrected thyroid function
- •severe kidney disorder (creatinin >2,5mg%)
- •no written patient consent
- •insufficient patient compliance
- •participating in another study
- •life expectancy < 1 year due to other severe disease
- •age < 18 years
- •no contraception (young women) or pregnancy
研究组 & 干预措施
A
Active Comparator
Conventional Biventricular Stimulation: RV Apex and LV Lead Tip
干预措施: Device Implantation (Device)
B
Active Comparator
Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V".
干预措施: Device Implantation (Device)
C
Active Comparator
Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His
干预措施: Device Implantation (Device)
结局指标
主要结局
Improvement according to Packer's "Heart Failure Clinical Composite Respond"
时间窗: 12 months post implant
次要结局
- Change in B-type natriuretic Peptide (BNP)-Concentration(12 months)
- 6 min walk test(12 months)
- Intraoperative Increase in Left Ventricular dp/dt(At Implant)
- QoL assessment("Minnesota Living with Heart Failure = MLHF)(12 months)
- Cardiopulmonary Capacity(Spiroergometry)(12 months)
- 2D-echo optimized EF(12 months)
- 12 channel ECG(12 months)
- Complications and morbidity(12 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of Site of Right Ventricular (RV) Pacing on RV Function, Left Ventricular (LV) Dyssynchrony and Contraction EfficiencyHeart BlockHeart Block CompleteSystolic FunctionNCT06636851South Valley University52
已完成
不适用
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuideHeart FailureNCT01917266Abbott Medical Devices40
Unknown
不适用
Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative PositionBradycardiaHeart BlockSick Sinus SyndromeNCT01647490Ospedale Santa Maria di Loreto Mare408
Unknown
不适用
Right Ventricular Resynchronization TherapyRight Ventricular FailureChronic Thromboembolic Pulmonary HypertensionPulmonary HypertensionNCT01163422Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)20
已完成
不适用
Trip HF Study: Triple Resynchronization in Paced Heeart Failure PatientsVentricular DyssynchronyHeart FailureNCT00187265Abbott Medical Devices