Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement. The PROMOTE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm
研究概览
简要总结
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of a large proportion of such patients. The implementation of a pre-specified treatment strategy translating into a more uniform practice regarding the management of conduction disturbances post-TAVR applied to a large cohort of patients would permit to identify the benefits and drawbacks of each specific aspect of the treatment algorithm proposal. This may also help to improve both the management and clinical outcomes of the complex group of patients with conduction disturbances associated with TAVR. In the end, the final objective of a pre-specified strategy for managing conduction disturbances post-TAVR should be to obtain a low rate of PPM without increasing the risk of sudden death or life threatening arrhythmic events following hospital discharge, and all this while avoiding an excessive prolongation of the hospitalization period following the TAVR procedure.
详细描述
The objectives of the study are:
- Feasibility: to validate and determine the applicability of a pre-specified algorithm for managing conduction disturbances in consecutive patients undergoing TAVR, also evaluating the percentage of patients included in each group of the algorithm strategy.
- Efficacy: (i) to evaluate the rate of permanent pacemaker implantation in-hospital and at 30 days compared to that of the year prior to the implementation of the protocol, (ii) to determine the incidence of sudden death at 30 days and at 1-year follow-up.
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
- 是
入选标准
- •Patients with aortic valve disease undergoing transcatheter aortic valve replacement
排除标准
- •Prior permanent pacemaker
- •Failure to provide signed informed consent for data collection
- •Impossibility for a follow-up
- •Unwillingness to follow the pre-specified strategy for the management of conduction disturbances
结局指标
主要结局
Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm
时间窗: 1 year follow-up
Incidence of permanent pacemaker implantation
时间窗: At 1-year follow-up
Incidence of sudden death
时间窗: At 1-year follow-up
次要结局
- Rate and timing of sudden death(At 1-year follow-up)
- Factors associated with sudden death or permanent pacemaker implantation(At 1-year follow-up)
- Evaluation of the rate and timing of permanent pacemaker implantation(After hospital discharge (up to 1-year))
- Evaluation of arrhythmic events in patients with continuous ECG monitoring(After hospital discharge (up to 1-year))
- Rate of PPI among valve types(At 1-year follow-up)
- Pace dependency and pacing rate(At 1-year follow-up)
- Rate, timing of and reasons for permanent pacemaker implantation(At 1 year follow-up)
研究者
Josep Rodes-Cabau
Principal Investigator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec