The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2,718
- 主要终点
- Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
研究概览
简要总结
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.
详细描述
Atrial fibrillation (AF) and atrial flutter (AFL) are common cardiac arrhythmias associated with an increased incidence of stroke in patients with additional risk factors. Oral Anticoagulation (OAC) reduces stroke risk, but because these arrhythmias are frequently intermittent and asymptomatic, start of OAC therapy is often delayed until electrocardiographic documentation is obtained.
Technological advances in implanted dual-chamber cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) devices allow early detection and real time verification of AF/AFL with intracardiac electrograms (IEGM) automatically transmitted to the clinicians. Such remote diagnostic capability might be particularly relevant in patients with asymptomatic AF by allowing timely treatment. Compared to conventional periodic, (e.g., quarterly) office device evaluation, daily remote monitoring may prove superior for diagnosis of AF and prophylactic treatment of thromboembolism.
The start, stop and restart of OAC based on a predefined atrial rhythm-guided strategy in conjunction with a standard risk-stratification scheme could lead to better clinical outcomes compared with conventional clinical care. The study is designed to demonstrate a risk reduction of both thromboembolism proximate to episodes of documented AF/AFL and bleeding potentiated by chronic OAC in the absence of AF. Verification of this premise would impact the clinical practice, providing evidence to physicians for the use of HM to guide OAC in patients with AF/AFL. The results of this study should demonstrate the clinical value of wireless remote surveillance of the cardiac rhythm and may define the critical threshold of AF/AFL burden warranting OAC or antiarrhythmic drug therapy in patients at risk of stroke
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •Candidates for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or DR-T device
- •Documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrollment, if previously implanted
- •CHADS2 risk score ≥ 1
- •Able and willing to follow OAC therapy if the indication develops during the course of the trial
- •Able to utilize the HM throughout the study
排除标准
- •Permanent AF
- •History of stroke, transient ischemic attack (TIA) or systemic embolism and documented AF or AFL
- •Currently requiring OAC therapy for any indication
- •Patients who underwent successful AF ablation (sinus rhythm restored) and have not completed a minimum of 3 months of OAC therapy
- •Known, current contraindication to use of eligible OAC
- •Long QT or Brugada syndrome as the sole indication for device implantation
- •Life expectancy less than the expected term of the study
研究组 & 干预措施
Home Monitoring Guided OAC
Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of OAC.
干预措施: Home Monitoring Guided OAC (Drug)
Physician-Directed OAC
In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed OAC consistent with current standards of care.
Safety Net data include:
- ERI/EOS
- Special Implant Status
- Implant in Backup Mode (ROM)
- VT/ VF Detection Inactive
- Emergency Pacing
- 250 Ω > RV Pacing Impedance > 1500 Ω
- Symptomatic VT/VF therapies including both ATP and shock
- VT/VF storm
- HM transmission failure >3 days
干预措施: Physician-Directed OAC (Drug)
结局指标
主要结局
Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
时间窗: From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years
The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.
次要结局
- Rates of All-cause Mortality(Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years)
- Rate of Ischemic and Hemorrhagic Stroke(Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years)
- Rate of Major Bleeding Events(Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years)
- Change in Quality of Life Score(1 year)
- Mean Ventricular Heart Rate Reduction(1 year)
- Rate of Fatal or Disabling and Non-disabling Stroke(Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years)
- Mean Atrial Fibrillation/Atrial Flutter Burden(Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years)
- Rate of Cardioembolic and Non-cardioembolic Stroke(Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years)