"Tasso di Stimolazione Ventricolare Nel Follow-up Dei Pazienti Sottoposti ad Impianto di PM Post TAVI:Fattori Predittivi ed Evoluzione Clinica"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- ventricular pacing rate
研究概览
简要总结
The goal of this observational study is to learn about the effective ventricular pacing rate in follow-up of patients who underwent a pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI).
Secondly the study want investigate possible conduction recovery in follow up of patients and possible predictive factors of different ventricular pacing rates.
详细描述
Aortic stenosis represents the most common valve defect in developed countries. Percutaneous transcatheter aortic valve implantation (TAVI) is now a first-line therapy for aortic stenosis.
The development of conduction blocks remains one of the most frequent complications of TAVI (3-26%), requiring the implantation of a permanent pacemaker (PM).
The damage caused to the conduction system during TAVI is the consequence of the anchoring of the prosthesis to the membranous septum.
There are several clinical, procedural and anatomical variables that correlate with a higher risk of permanent PM implantation post-TAVI, including age, pre-existence of BBDX, development of BBSX post TAVI, use of self-valves -expanding and implantation depth of the bioprosthesis.
Some anatomical variables, obtained from the CT study, appear to correlate with a greater risk of damage to the conduction system post-TAVI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •PM implantation following TAVI surgery, during the same hospitalization
- •Signature of informed consent
- •Over the age of 18.
排除标准
- •PM implantation prior to hospitalization for TAVI
- •PM implantation during hospitalization different from the hospitalization for TAVI
- •Pregnant or breastfeeding women
结局指标
主要结局
ventricular pacing rate
时间窗: 1 year
次要结局
未报告次要终点