Remote ECG Monitoring as a Diagnostic Tool for Therapeutic Strategies After Transcatheter Aortic Valve Replacement: Rationale and Design of the DRAGON-TAVI Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block.
研究概览
简要总结
The DRAGON TAVI study is a multicenter, prospective, open, randomised trial, which will enrol 250 patients, randomized 1:1 to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and standard care (ie. control group, which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days). The duration of the study is 12 months ± 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patient age over 18 years old
- •Severe aortic stenosis
- •Moderate or high cardiovascular risk based on current ESC Guidelines "Heart Team" qualification for TAVI
- •Written informed consent of the patient for participation in the study
排除标准
- •History of atrial fibrillation or atrial flutter
- •Previously known conduction disturbances**
- •Presence of: pacemaker, CRT-P, ICD, CRT-D before or after TAVI
- •Ischaemic stroke, TIA, MI or heart surgery within 1 month before TAVI qualification
- •Haemorrhagic stroke within 1 year before TAVI qualification
- •Chronic immunosuppressive therapy
- •Comorbidities (e.g. drug addiction, alcohol abuse, emotional/mental disorders) which do not allow safe participation in the study
研究组 & 干预措施
Remote ECG monitoring
Device: continuous 30-day ECG monitoring with visits triggered by ECG findings
干预措施: Remote ECG monitoring (Device)
Standard care
Control group, which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days
干预措施: Standard Care (in control arm) (Device)
结局指标
主要结局
The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block.
时间窗: 30 days
次要结局
- Secondary endpoints will include: All-cause mortality; Major composite adverse cardiovascular events (MACEs, ie, cardiovascular death, stroke, myocardial infarction, hospitalisation for heart failure); Episodes of syncope; cardiac arrhythmias(24 months)
研究者
Wojciech Wańha
MD, PhD, Prof.
Medical University of Silesia