Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Surgical success
研究概览
简要总结
Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required, and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is a randomized controlled trial that compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block.
详细描述
Over the past several years, there has been growing concern over the significant deleterious effects of RV pacing, including electromechanical dyssynchrony, proarrhythmia and development of heart failure (HF). However, it remains unclear whether pacing-related ventricular dyssynchrony can translate into significant LV structural changes and produce important clinical impairment in an average pacemaker population with compromised AV conduction. Alternatively, left ventricular pacing has been shown to minimize ventricular dyssynchrony and to improve symptoms and prognosis in patients with mild to moderated systolic HF and prolonged QRS duration.
This randomized controlled study is been conducted to compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block. The hypothesis is that isolated LV pacing through the coronary sinus can be used safely and provide greater hemodynamic benefits to patients with AV block and normal ventricular function who require only the correction of heart rate.
Specifically, the investigator aims are to evaluate the safety, efficacy and the effects of left ventricular pacing using active-fixation coronary sinus lead-the Attain StarFix® Model 4195 OTW Lead, compared to right ventricular pacing in patients with implantation criteria for conventional pacemaker stimulation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years
- •Pacemaker initial implant by transvenous approach
- •Presence of AV block
- •Presence of atrial fibrillation / atrial flutter with slow ventricular response
- •Left ventricular systolic function > 0.40
- •Subject agreed to participate and signed the consent form
排除标准
- •Absence of venous access
- •Impediment of venous access due to presence of intracardiac defects
- •Impediment of venous access due to presence of tricuspid valve prosthesis
- •Need for radiotherapy in the chest
- •Presence of chest deformity
- •Pregnancy
- •Life expectancy of less than one year
- •Contraindication to administration of iodinated contrast (creatinine > 3.0) Unable to attend the follow-up appointments
结局指标
主要结局
Surgical success
时间窗: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days
Surgical success: absence of complications
次要结局
- Echocardiographic and Clinical composite(Participants will be evaluated at 6 and 24 months after PM implantation)
研究者
Roberto Costa
Associated Professor of Cardiovascular Surgery, MD PhD
University of Sao Paulo