Ventricular Pacing Site Selection (V-PASS)
2011年8月1日 更新者：Medtronic BRC
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.
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.
研究概览
地位
未知
条件
详细说明
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.
研究类型
介入性
注册 (预期的)
100
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Matthias E Reimers, Dipl. Documentalist
- 电话号码：422 0049021152930
- 邮箱：Matthias.reimers@vitatron.com
研究联系人备份
- 姓名：Steffen Gazarek, Dr., Engineer
- 电话号码：004901729135662
- 邮箱：steffen.gazarek@vitatron.com
学习地点
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Bad Krozingen、德国、D-79189
- 招聘中
- Herzzentrum Bad Krozingen, Elektrophysiologie
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接触：
- Jochem Stockinger, MD
- 电话号码：248 0049 07633402
- 邮箱：JFStockinger@gmx.de
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首席研究员：
- Jochem Stockinger, MD
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副研究员：
- Thomas Blum, MD
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Heidelberg、德国、D-69120
- 尚未招聘
- Universitätsklinikum Heidelberg, Innere Medizin III
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接触：
- Alexander Bauer, MD
- 电话号码：8672 ++49 0622563
- 邮箱：Alexander.Bauer@med.uni-heidelberg.de
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首席研究员：
- Alexander Bauer, MD
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Wangen、德国、D-88239
- 尚未招聘
- Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.
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接触：
- Jörg Maurus, MD
- 电话号码：1311 0049 00752296
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首席研究员：
- Jörg Maurus, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
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%
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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Amount of patients in which the ventricular lead position could be positioned successfully according randomization
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次要结果测量
结果测量 |
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心脏衰竭
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Typical values re operation procedure in both groups
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operation time, x-ray time
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intraoperative measurements (amplitudes, thresholds)
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broad QRS-complexes in both groups
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safety of therapy, complications
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electrical specific values in both groups
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energy consumption, lead impedance
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Rhythmologic characteristics in both groups
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amount of VESs
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episodes of ventricular tachycardia
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amount of atrial and ventricular stimulation
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BNP-levels in both groups
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incidence of co-morbidities in both groups
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Atrial Fibrillation, AF burden >1%
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Heart failure > NYHA II
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Hospitalizations in both groups due to
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Rhythm disorders
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Giudici MC, Thornburg GA, Buck DL, Coyne EP, Walton MC, Paul DL, Sutton J. Comparison of right ventricular outflow tract and apical lead permanent pacing on cardiac output. Am J Cardiol. 1997 Jan 15;79(2):209-12. doi: 10.1016/s0002-9149(96)00718-7.
- Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.
- Fachgruppe Herzschrittmacher. Bericht des Deutschen Herzschrittmacher Registers 2003 http://www.pacemaker-register.de/pdf/zentralregister_herzschrittmacher_bericht03.pdf
- DÄNISCHES HERZSCHRITTMACHERREGISTER http://www.pacemaker.dk
- SCHWEIZER HERZSCHRITTMACHERREGISTER http://www.pacemaker.ch
- Lemke B., Nowak B. Pfeiffer D. Leitlinien zur Herzschritmachertherapie. Deutsche Gesellschaft für Kardiologie 2005. http://www.dgk.org/leitlinien/LLHerzschrittmacher.pdf
- Gregoratos G., Abrams J. Epstein AE, et al. ACC/AHA /NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation)(2002). http://www.acc.org/clinical/guidelines/pacemaker/pacemaker.pdf
- Frohlig G, Schwaab B, Kindermann M. Selective site pacing: the right ventricular approach. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):855-61. doi: 10.1111/j.1540-8159.2004.00547.x.
- Koglek W, Kranig W, Kowalski M, Kronski D, Brandl J, Oberbichler A, Suntinger A, Wutte M, Grimm G, Grove R, Ludorff G. [A simple method for AV-delay determination in dual chamber pacemakers]. Herzschrittmacherther Elektrophysiol. 2000 Dec;11(4):244-53. doi: 10.1007/s003990070023. German.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
研究完成
2008年12月1日
研究注册日期
首次提交
2006年2月14日
首先提交符合 QC 标准的
2006年2月14日
首次发布 (估计)
2006年2月15日
研究记录更新
最后更新发布 (估计)
2011年8月2日
上次提交的符合 QC 标准的更新
2011年8月1日
最后验证
2007年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.