Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
研究概览
简要总结
Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex. It is mainly limited by a high proportion of non-responders. Attempts have been made, in small studies, to increase the number of stimulation sites in order to optimize the resynchronization therapy. V3 is a planned multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred by the addition of a second endocardial or epicardial LV lead in non-responders after at least 6 months of standard biventricular stimulation.
The V3 trial will examine the clinical benefit conferred by the addition of a second LV lead in non-responders compared to standard 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
- Single (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
- •Age greater than 18 years
- •Recipient of a CRT-P or CRT-D system for greater than 6 for standard indications, including LV ejection fraction greater than 35 percent and New York Heart Association (NYHA) functional class III or IV
- •Optimized biventricular stimulation and medical therapy since implantation of the system
- •Presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block
- •Greater than 93 percent LV stimulation since the last device interrogation, with a LV capture threshold less than 5.0 Volts/0.5 milliseconds
- •Unchanged or worsened clinical status by CRT, according to the HF composite endpoint described by M. Packer, in absence of a reversible cause
- •Signature of a written, informed consent to participate in the trial
排除标准
- •LV lead location in the great cardiac vein
- •Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
- •Chronic renal dialysis
- •Concomitant disorder which might interfere with the results of the V3 trial
- •Blood systolic pressure greater than 180 millimeters of mercury (mmHg) or diastolic pressure greater than 95 mmHg despite optimal medical management
- •History of stroke, myocardial infarction or unstable angina pectoris within the last 3 months
- •Presence of correctible valvular disease
- •Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent
- •Subject is pregnant
- •Subject participates in another research project
结局指标
主要结局
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
时间窗: 12 months
M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved. Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened. Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved. Unchanged : if none of the previous definition applies.
次要结局
- Rate of Adverse Events(24 months)
- Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study(24 months)
- Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study(24 months)
- Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire(24 months)
- Changes in Echocardiographic Indexes of Left Ventricle Remodeling(24 months)
- Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score(24 months)
- Time to First Heart Failure Related Hospitalization(24 months)
- Overall Mortality(24 months)