A Continuous ECG Monitoring Data Collection Study in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR) to Evaluate the Performance of the Cara Monitor Conduction Disturbance Risk Score (CDRS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 355
- 试验地点
- 3
- 主要终点
- Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor
研究概览
简要总结
Prospective, non-randomized, multicenter data collection study. Eligible TAVR patients will be enrolled in the study.
Cardiac conduction disturbances (CD) requiring permanent pacemaker implantation (PPM) or causing new-onset CD are frequent complications of TAVR that have been shown to be associated with increased mortality and re-hospitalization rates.
The purpose of the study is to collect continuous ECG data in order to validate the performance of the Cara Conduction Disturbance Risk Score (CDRS) in patients undergoing transcatheter aortic valve replacement (TAVR).
Subjects will be studied during the TAVR procedure and their ECG recordings according to the study schedule below of pre-, during, and after the TAVR procedure up to 14/30 days FU will be collected.
600 patients will be enrolled in this study with the hypothesis that Cara can deliver a statistically significant conduction disturbance risk stratification for patients undergoing TAVR.
No investigation intervention is planned during this study. The Cara System analysis will be performed offline.
详细描述
TAVR will be performed using site investigators' best practices including the use of standard-of-care catheters, devices, imaging, and monitoring modalities.
Data will be collected to include the following patients' measures during this study:
-
Pre-procedure
-
Demographics
-
Medical history
-
Cardiac CT
-
12 lead ECG
-
Procedure
-
Continuous 3-12 lead Holter will be supplied, data will be collected and analyzed by the study sponsor
-
Fluoroscopy (captured automatically by video system )
-
Device manufacturer (type) and size
-
Post-procedure (in hospital)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Must meet be ≥ 18 years of age.
- •Must meet indications for TAVR using approved devices
- •Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- •Willing to comply with specified follow-up evaluations.
- •Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements.
排除标准
- •Any implanted device or an indication for treatment with a rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT), or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline.
- •Any contraindication to the TAVR procedure according to the instructions for use.
- •Less than the legal age of consent, legally incompetent, or otherwise vulnerable.
- •Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period.
结局指标
主要结局
Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor
时间窗: 14 days
Continuous ECG data collected during the TAVR procedure will be used to retrospectively evaluate the performance of the Cara monitor Conduction Disturbance Risk Score (CDRS) in patients post- TAVR procedure. Measured output: 1. Patients who receive PaceMaker (PPM) 14 days following TAVr (PPM+) 2. Patients that do not receive PaceMaker (PPM) 14 days following TAVr (PPM-)
次要结局
未报告次要终点