Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation - an International Multicenter Collaborative Study Group
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 25
- 主要终点
- Descriptive characterization of patients
研究概览
简要总结
The investigators aim to characterize patients presenting with a severe ventricular tachycardia (VT) and premature ventricular complex (PVC)-ablation-related complication including patient characteristics, procedural details and subsequent management of the complication by gathering existing patient-level data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Centers : Centers participating in the present collaborative study group. Invitation to participate will be based either upon personal referral of one of the investigator, previous collaboration or based on a meta-analytic review of the literature published on the subject within the past 20 years.
- •Patients: Females and males of >18 years undergoing any type of VT/PVC ablation. While we will accept redo-procedure we will ask for a unique patient-identifier to link procedures belonging to the same patients together.
- •Interventions: VT/PVC ablation (first intervention or re-do) as routinely performed by the participating centers
- •Outcomes: Severe complications, defined as hemodynamic instability requiring mechanical intensive-care management, tamponade, stroke, cardiac arrest, myocardial infarction, phrenic nerve palsies, major bleeding requiring transfusion, vascular or cardiac complication requiring surgery, procedure-related death.
- •Setting: Observational cohort studies, registries, retrospective cohort studies. Data stemming from RCTs (Randomized controlled trials) will not be collected as they likely do not represent a "real-life" setting.
- •Length of follow-up: Peri-procedural complications
- •Years considered: Not limited to a specific time-frame, but to reflect common ablation practices, we will focus on data from the 20 past years.
- •Number of patients provided : No lower limit of patients provided per dataset or ablation volume per year to include high- as well as low-volume centers
排除标准
- •Refusal of the center to participate.
- •Less than 10 procedures available in the dataset (no case reports)
- •Missing essential baseline characteristics, missing collection of sufficient details regarding each complication.
结局指标
主要结局
Descriptive characterization of patients
时间窗: up to 30 days
characterizing features: * hemodynamic instability requiring mechanical intensive-care management * tamponade * stroke * cardiac arrest * myocardial infarction * coronary artery dissection * phrenic nerve palsy * major bleeding as per the International Society on Thrombosis and Haemostasis (ISTH) * vascular or cardiac complication requiring surgery or interventional management (interventional radiology, angiology) * iatrogenic atrio-ventricular block requiring device implantation or upgrade. * procedure-related death
次要结局
- Prevalence of each severe complication(up to 30 days)
- Difference in baseline characteristics between the patients who experienced a complication and the ones who did not(up to 30 days)
- The contribution of important baseline and procedural characteristics to the occurrence of a severe complication(up to 30 days)
- Impact of center-specific data on the occurrence and management of these complications(up to 30 days)