Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Rate of effective same-day discharge
研究概览
简要总结
Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). As a consequence, the need for prolonged in-hospital monitoring after LP implantation though the right femoral (RF)vein is a barrier to same-day discharge. Recently, right internal jugular (RIJ) vein access has emerged an alternative to right RF vein access for LP implantation (with a regulatory approval for MEDTRONIC Micra LP).
The aims of this registry are the following :
- evaluate the feasibility of RIJ access for LP implantation;
- confirm the acute and chronic safety of RIJ access for LP implantation;
- compare RIJ to RF (historical cohort) vein access regarding procedural characteristics and outcomes;
- evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Indication of pacemaker implantation
- •Eligible to leadless pacemaker
排除标准
- •Contraindication to right internal jugular vein access
- •Age < 18 year-old
- •Patient already included in a clinical study
结局指标
主要结局
Rate of effective same-day discharge
时间窗: [0 - 1 Month]
Feasibility of same-day discharge after implantation of a leadless pacemaker through the jugular vein, defined as a successful same-day discharge with no readmission during the first postoperative month.
Rate of effective of jugular access
时间窗: [0 - 1 Month]
Feasibility of jugular access for leadless pacemaker implantation, defined as the percentage of patients with a successful leadless pacemaker implantation through the jugular vein.
Incidence of major cardiovascular event
时间窗: [0 - 12 Month]
Incidence of major complications related to the implantation of a leadless through the jugular vein: * pericardial complications (effusion, tamponade, pericardiocentesis) * jugular venous complications (bleeding, hematoma, arteriovenous fistula, vascular surgery) * carotid artery complications (bleeding, transient ischemic attack or stroke, vascular surgery) * pacemaker malfunction * infection * cardiac rhythm complications (atrioventricular block, ventricular fibrillation ou tachycardia, cardiac arrest) * air embolism
次要结局
- Description of procedural characteristics(During implantation procedure)