A Randomized, Prospective Multicenter Pilot Study to Determine the Influence of the Ventricular Pacing Site on the Incidence of Atrial Fibrillation and Heart Failure in Patients With Indication for Permanent Pacemaker Stimulation Therapy.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Amount of patients in which the ventricular lead position could be positioned successfully according randomization
研究概览
简要总结
The purpose of this study is to determine whether there is a relationship between ventricular lead position and the incidence of heart failure and atrial fibrillation in patients with indication for permanent pacemaker stimulation.
详细描述
AV-Block of higher degree is the primary indication for pacing therapy for about 20% of pacemaker patients. Pacing systems with only ventricular stimulation (VVI and VDD) have a fraction of about 40% of all pacemakers in Germany. About 50% of the implanted pacemakers in Germany are dual-chamber pacemakers and one half of them is used for treatment of AV blocks.
Picture 1: Fractions of pacing indications in Germany Picture 2: Fractions of used pacing modes in Germany /1/
A lot of studies proved in the past that the pacing site influenced the development of hemodynamics, heart failure (HF) and atrial fibrillation (AF). Unfortunately, the results are not commonly applicable or statistically assured. Due to this, further examinations are required in order to get explicit statements regarding application of alternative, nonapical ventricular lead positioning.
- Pilotphase It shall be determined whether a randomized positioning of ventricular leads at 2 defined positions (either Group A: Positioning at right ventricular apex or Group B:. Positioning at right ventricular high septum) is feasible. Included patients will already by examined and followed according to protocol. After having proved feasibility of randomized positioning, the data of these patients shall be used for evaluation of the V-PASS study.
- Study Phase It shall be evaluated how far 2 defined different ventricular lead positions for permanent pacemaker therapy can influence the combined study endpoint mortality and clinically relevant symptoms of heart failure. Further more the development of hemodynamics and the incidence of atrial fibrillation shall be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients with an expected ventricular stimulation rate of >60% in planned pacing therapy. This will be the following pacing indications
- •Symptomatic first-degree AV block, PQ time >250ms
- •Second-degree Av block with permanent 2:1 conduction
- •Permanent third-degree AV block
- •Paroxysmal first-degree to third-degree Av block, with an anticipated rate of ventricular stimulation >60%
- •Symptomatic bradyarrhythmia absoluta with permanent atrial fibrillation, with an anticipated rate of ventricular stimulation >60%
排除标准
- •heart failure acc. NYHA III or IV
- •Intra-atrial conduction delay (P-wave > 150ms)
- •Myocardial infarction less then 6 months before pacemaker implant
- •hypertrophic obstructive cardiomyopathy
- •Cardiogenic shock
- •pregnancy
- •Lactation period
- •Patients under 18 years of age
结局指标
主要结局
Amount of patients in which the ventricular lead position could be positioned successfully according randomization
次要结局
- Atrial Fibrillation, AF burden >1%
- Typical values re operation procedure in both groups
- operation time, x-ray time
- intraoperative measurements (amplitudes, thresholds)
- broad QRS-complexes in both groups
- safety of therapy, complications
- electrical specific values in both groups
- energy consumption, lead impedance
- Rhythmologic characteristics in both groups
- amount of VESs
- episodes of ventricular tachycardia
- amount of atrial and ventricular stimulation
- BNP-levels in both groups
- incidence of co-morbidities in both groups
- Heart failure > NYHA II
- Hospitalizations in both groups due to
- Heart failure
- Rhythm disorders