NCT01515761Unknown不适用
POsition of Leads in Advanced heaRt Failure: the POLAR Study - A 6 Month, Observational, Mult-centered, Blinded, Randomized Study to Determine if Lead Positioning in the Lateral Wall of LV in Patients Meeting Criteria for CRT Plays a Role in Determining Myocardial Function and Affect the Severity of Mitral Regurgitation
Sergio Thal, M.D.4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in 6 minute walk tests
研究概览
简要总结
The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.
详细描述
This is a 6 month, multi-centered, blinded, randomized study. Approximately 60 patients will join this study. Two groups, based on lead position, will be studied with thirty (30) patients randomized into each group.
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
- •Subject meets the general indications for an implantable cardioverter defibrillator (ICD) with LV systolic function ≤ 35% as defined by echocardiography.
- •Subject has moderate or severe heart failure, defined as NYHA Class III-IV for at least 90 days prior to enrollment.
- •Subject has optimal pharmacological heart failure therapy for at least 30 days prior to enrollment.
- •Subject has a 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm and PR interval < 320 ms measured from any two leads.
- •12 lead ECG with left bundle brunch block morphology and a QRS duration of at least 120 msec.
- •Subject has creatinine < 2.5 mg/dL obtained no more than 30 days prior to enrollment.
- •Subject has left ventricular ejection fraction < 35% by echocardiogram no more than 1 year prior to enrollment.
- •Subject is willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation.
- •Subject has a life expectancy of more than 180 days, per physician discretion.
- •Subject is age 18 or above, or of legal age to give informed consent specific to state and national law.
排除标准
- •Subject has right bundle branch block morphology on a 12-lead ECG obtained no more than 90 days prior to enrollment.
- •Subject had previous cardiac resynchronization therapy, a previous coronary venous lead, or meets the general indications for anti-bradycardia pacing defined as ventricular pacing > 40% by pacemaker interrogation.
- •Subject has a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking.
- •Subject has an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 30 days prior to enrollment.
- •Subject currently requires dialysis.
- •Subject has severe chronic obstructive pulmonary disease (COPD), defined as FEV1/FVC < 60%, or as defined by a physician.
- •Subject has had a myocardial infarction within 30 days prior to enrollment or coronary artery disease (CAD) in which surgical or percutaneous correction was performed within 30 days prior to enrollment.
- •Subject has hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
- •Subject is on IV inotropic agents.
- •Subject has any mitral valve prosthesis, or a mechanical aortic or tricuspid prosthesis
- •Subject is enrolled in any concurrent study, without Medtronic written approval, which may confound the results of this study.
- •Subject is pregnant or planning to get pregnant.
- •Subject requires oxygen for medical reasons other than CHF.
结局指标
主要结局
Change in 6 minute walk tests
时间窗: 6 weeks, 3 and 6 months
Change (reduction) in left ventricular end systolic volume (LVESV)
时间窗: 3 and 6 months
次要结局
- Chronic heart failure hospitalizations(Monitored during study participation ~ 6 months)
- Myocardial performance as measured by myocardial performance index (MPI)(6 months)
- Papillary muscle velocity as determined by tissue doppler(6 months)
- Minnesota living heart failure survey(6 weeks, 3 and 6 months)
- Progression of mitral regurgitation(6 months)
研究者
Sergio Thal, M.D.
Electrophyisology Laboratory Director
Southern Arizona VA Health Care System
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Optima Coronary Artery Disease (CAD) (Optimal Mechanical Evaluation)Heart FailureIschemic CardiomyopathyNCT00896142University of Pittsburgh50
已完成
不适用
Optimizing Left Ventricular Lead To Improve Cardiac OutputIschemic Congestive CardiomyopathyCongestive Heart FailureDilated CardiomyopathyNCT01399801Ann Marie Chikowski12
已完成
不适用
Targeted left ventricular lead placement in cardiac resynchronisation therapyHeart failureISRCTN19717943Papworth Hospital NHS Foundation Trust (UK)220
已完成
早期 1 期
Characterization of Interventricular Conduction MeasurementsHeart FailureNCT01362465Medtronic Cardiac Rhythm and Heart Failure25
已完成
不适用
Model 4396 Left Ventricular (LV) Lead StudyHeart FailureNCT00853593Medtronic Cardiac Rhythm and Heart Failure197