Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Atrial fibrillation
研究概览
简要总结
Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days after surgery.
详细描述
Pre market single center clinical research feasibility study. Non blinded randomized controlled study. 52 patients undergoing CABG procedure will be enrolled and randomized into two different group (26 person each): the Spinal Cord Stimulation (SCS) and the control group. The first group will be implanted before the CABG procedure with a temporary SCS lead (5 days) while the second one will not. The lead will be connected to an external stimulator.
The day of the CABG surgery, before the scheduled procedure, the patients in the treatment group will be implanted with the SCS lead. CABG procedure follows the SCS lead implantation. SCS will be switched off before surgery.
After the CABG procedure, all patients will be hospitalized for minimally five days at the end of which they will be discharged. The Primary Endpoint data will be collected from the day of CABG procedure (Day-0) until Day-5. SCS lead will be removed on Day-5.
1-week follow up visit will be performed one week after discharge. End-points will be evaluated at various time before, during and after surgery. In both groups arrhythmic episodes for primary and secondary endpoints will be recorded via a Holter monitor (recording 5 days continuously).
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
- 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 which will be subjected to an OFF-pump CABG procedure
- •More than 18 years of age
- •Subject is able and willing to give informed consent.
排除标准
- •Patients with known history of atrial arrhythmias.
- •Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
- •Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
- •Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
- •Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
- •Hypotension (RR systolic <100 or RR diastolic <50).
- •Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.
- •Subject is diagnosed with epilepsy or history of seizures.
- •Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures
- •Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.
- •Patients with long QT syndrome.
- •Patients with Brugada syndrome.
- •Patients affected by Polyneuropathy (e.g. due to diabetes).
- •Patients affected by pericarditis
- •Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:
- •Ablation procedure
- •Cardiac surgery
- •Pregnant patients or nursing (subjects who are of child bearing potential and are not on a reliable form of birth control will undergo a pregnancy test)
- •Patients already implanted with cardiac devices
- •Patients with existing implanted neurostimulators
结局指标
主要结局
Atrial fibrillation
时间窗: 5 days after CABG
AT/AF will be defined as an episode with an atrial rate \>175 bpm lasting ≥ 20 seconds.
次要结局
- Cardioversion(5 days after CABG)
- BP(5 days after CABG)
- Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.(5 days after CABG)
- VT/VF episodes(5 days after CABG)
- Bladder function(5 days after CABG)
- Burden VT/VF episodes(5 days after CABG)
- HRV(5 days after CABG)
- Medication(5 days after CABG)
- Hospitalizations Days(1 week after discharge)
- Pain on the VAS scale(5 days after CABG)
- Description of the total number of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.(5 days after CABG)
- Premature atrial beats(5 days after CABG)
- HR(5 days after CABG)