CoreValve Advance-II Study: Best Practices Investigation of Patients Implanted With the Medtronic CoreValve Bioprosthesis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- New-onset Class I or II Indication for Permanent Pacemaker Implantation
研究概览
简要总结
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
详细描述
The purpose of the study was to investigate the rate of conduction disturbances after trans-catheter aortic valve implantation of the Medtronic CoreValve device, aiming to characterize best practices. The investigators did not assign study specific interventions to the subjects in the study.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilling the criteria of labeling indications of the CoreValve System;
- •Patient is above the minimum age as required by local regulations to be participating in a clinical trial regardless of gender and race;
- •Provided Signed Informed Consent or Data Release Form.
排除标准
- •Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator);
- •Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines;
- •Persistent or permanent atrial fibrillation (except paroxysmal AF);
- •Participation in another drug or device study that would jeopardize the appropriate analysis of endpoints of this study.
- •High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- •Pregnancy
结局指标
主要结局
New-onset Class I or II Indication for Permanent Pacemaker Implantation
时间窗: 30 days post procedure
The Kaplan-Meier estimate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or \>6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines.
次要结局
- Combined Safety Endpoint(30 days post procedure)