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临床试验/NCT02522364
NCT02522364Unknown不适用

Subclinical Postoperative Atrial Fibrillation

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Device extraction

研究概览

简要总结

Postoperative atrial fibrillation and atrial flutter (POAF) is the most common complication after cardiac surgery requiring intervention or prolonged hospital stay.

POAF is associated with higher mortality and higher risk of thromboembolic events.

However, It is yet unknown whether a now event of postoperative atrial fibrillation is an indication of a chronic arrhythmic disease - a tendency towards developing recurrent atrial fibrillation or merely a response to the stress of surgery with not recurrence. This distinction is critical to determine the appropriate therapy. Since recurred events of atrial fibrillation (Paroxysmal atrial fibrillation) are associated with long term risk for stroke and thromboembolic evens patients with PAF are treated with long term anticoagulation. Missing the long term recurrence of arrhythmia may result in under-treatment and pose a significant risk of stroke.

Bio-Monitor is a subcutaneous implanted device that automatically detects arrhythmias and stores electrocardiogram (ECG) recordings. It will enable the detection of atrial fibrillation over a period of years and allow correct diagnosis and appropriate treatment.

The purpose of the study is to study the long term behavior of POAF, determine the likelihood of developing paroxysmal atrial fibrillation in patients with POAF and to define the risk factors for this eventuality

详细描述

Clinical background:

Postoperative atrial fibrillation and atrial flutter (POAF) is the most common complication after cardiac surgery requiring intervention or prolonged hospital stay . Affecting 10-65% of patients , this arrhythmia is associated with increased mortality, considerable morbidity including systemic therombo-embolism and hemodynamic deterioration. Often it will prolong the hospital stay and increase health costs. Notably, the incidences of POAF is increasing resulting from an increase in the average age and arrhythmic risk factors in patients undergoing cardiac surgery.

Although a lot of POAFs occur in patients with a history of PAF, there is an important portion of POAF in patients who have never experienced AF before. In some of these patients POAF may be the first manifestation of a tendency to fibrillate (that may have been silent prior to surgery) whereas in others it may be an acute response to the peri-operative stress that may never recur after the acute phase. A recent study has shown that patients with a first detected AF episode precipitated by a secondary event (the most common of which was cardiothoracic surgery) are very likely to have recurrent events. In fact the risk of recurrence was similar to that of patients with an AF event with an obvious precipitating factor Current guidelines mainly address the acute management of arrhythmia. Most conclude that anti-thrombotic therapy is indicated in POAF (IIA) usually if the arrhythmia persists for at least 48 hours. However this recommendation is based on very limited evidence as there is no substantial data describing the long term natural history of this complication. POAF was described as self-terminating but frequently recurrent with a complete resolution within 6-12 weeks . However, this observation was based on electrocardiogram follow-up with no continuous long term monitoring (ECG holter or loop recorder) and are therefore of limited validity. Emerging data suggests that AF recurrence rates may be significate ranging up to 24% over 6 years . Still, it is currently unknown how many of the patients presenting with an acute episode of POAF will develop recurrent events and when, as a result, there are no clear recommendations regarding the duration of anticoagulantion treatment. The current practice in cases of POAF of significant duration is to administer anti-coagulation therapy combined with antiarrhythmic (most often with amiodarone) for 6-12 weeks. The only guideline based recommendation that is based on poor evidence is to administer OAC to AF patients following CABG for at least 3 months . Holter ECG is routinely performed prior to the end of this period and if normal and clinical evaluation is normal the treatment is discontinued, usually with no additional evaluation.

Technical overview:

This study will be executed using the following devices and services:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • Newly documented POAF of more than 5 minute duration
  • cardiac surgery during index hospitalization, including (CABG, valvular replacement or repair, a combination) without Maze procedure
  • CHA2DS2-VASc≥2
  • Sinus rhythm at the time of BioMonitor implantation or definite intention to cardiovert prior to discharge
  • Signed Informed Consent

排除标准

  • History of atrial fibrillation/flutter prior to cardiac surgery
  • Contraindication for anticoagulation therapy
  • Dual chamber pacemaker or ICD implanted or planned
  • Active systemic infection
  • Another (non-AF) indication for long term anticoagulation
  • Maze procedure
  • Inability to attend scheduled, periodic office visits for follow-up
  • Pregnancy

研究组 & 干预措施

BioMonitor

Active Comparator

Participants randomized for this arm will be implanted with a BioMonitor device an implantable loop recorder inserted under the skin in the region of the thorax. It continuously records heart rhythm for a period of up to 7 years. The device will be interrogated at 1 month intervals. All arrhythmic events and conductive disturbances will be noted. In addition will be followed as specified in the standard arm

干预措施: BioMonitor device (Device)

Standard

Active Comparator

Participants randomized for this arm will be followed by biannual office visits initialing clinical evaluation, review of clinical events, review and update of medical therapy. Participants will undergo ECG holter examination at 3 and 6 months after discharge

干预措施: Standard (Other)

结局指标

主要结局

Device extraction

时间窗: 2 years

Implantation of ICD

时间窗: 2 years

Implantation of ICD following documented ventricular arrhythmia

Pocket site infection

时间窗: 2 years

The development of a Pocket site infection in the BioMonitor insertion site

MACCE

时间窗: 2 years

A composite of all -cause mortality, CT/MRI proven stroke, CT proven systemic embolism

Implantation of permanent pacemaker

时间窗: 2 years

Major bleeding

时间窗: 2 years

A composite of the following events: i. Bleeding resulting in a decrease in hemoglobin of ≥2 g/dL or over a 24-hour period ii. Bleeding leading to a transfusion of 2 or more units of packed red blood cells iii. Bleeding that occurs in a critical site (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome or retroperitoneal) iv. Bleeding that leads to death.

Pocket hematoma

时间窗: 30 days

The development of a hematoma in the BioMonitor insertion site

Atrial fibrillation event

时间窗: 2 years

Documented Atrial fibrillation of more the 5 minutes duration

次要结局

  • All -cause mortality(2 years)
  • CT/MRI proven stroke(2 years)
  • Initiation of long term anti-coagulation therapy(2 years)
  • Initiation of long term anti-arrhythmic therapy(2 years)
  • Rapid AF requiring hospitalization(2 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Prof. Michael Glikson

Director of Davidai Arrhythmia Center, Leviev Heart Center, Sheba Medical Center

Sheba Medical Center

研究点 (2)

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