CANadian Clinical Evaluation of the Automatic Arrhythmia DETECTion in SpiderFlash™ Device
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 101
- 试验地点
- 5
- 主要终点
- VT/VF sensitivity
研究概览
简要总结
This clinical investigation is a prospective, non-randomized, multi-center pivotal trial.
This trial aims to validate the automatic detection features provided by the external long-duration SpiderFlash-t™ Event recorder coupled with its analyser EventScope™, and to assess the performances of the Mode Switch function provided by Sorin Group Implantable Cardioverter-Defibrillators (ICDs).
This trial is being performed first in order to demonstrate the ventricular tachycardia (VT)/ ventricular fibrillation (VF) sensitivity of the automatic VT/VF detection function of the EventScope™ software.
Patients will be implanted with an ICD from Sorin Group, with PARAD+ arrhythmia detection enabled and Mode Switch (MS) algorithms activated in all patients.
Arrhythmic events will be documented over a period of 6 to 8 weeks for each patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients already implanted with an OVATIO DR or CRT-D device may be included in the study if they presented with at least one clinical VT/VF event at the follow-up visit preceding the enrolment.
- •ICD or CRT-D device upgrading or replacement are allowed but under the condition that existing bipolar RV sensing/pacing lead and/or defibrillation lead and/or LV pacing lead (where applicable) are not of poor or questionable integrity.
- •Patients with implanted pacemakers may be included in the study only if the pacemaker is to be explanted or otherwise disabled prior to implanting the ICD or CRT-D system, to avoid any potential pacemaker-ICD interactions.
- •Patients must comply with all the following criteria in order to be included in the CAN-DETECT study:
- •Patient is eligible for implantation of a dual-chamber ICD or a CRT-D device according to current available guidelines for primary or secondary ICD indication .
- •A stable, optimal (as determined by the enrolling physician) drug regimen
- •Scheduled for implant of an OVATIO DR Model 6550 or OVATIO CRT 6750 or an equivalent device from Sorin Group.
- •Signed and dated informed consent.
排除标准
- •Any patient complying with any of the following criteria cannot be included in the CAN-DETECT study:
- •Any contraindication for standard cardiac pacing
- •Any contraindication for ICD therapy
- •Permanent high-degree AV Block for patients planned for dual-chamber ICD implant only.
- •Permanent AF for patients planned for dual-chamber ICD implant only.
- •Abdominal implantation site
- •Acute myocarditis
- •Mechanical tricuspid valve
- •Heart transplant recipient
- •Already participating in another clinical study
- •Life expectancy less than 6 months
- •Inability to understand the purpose of the study or refusal to cooperate
- •Inability or refusal to provide informed consent
- •Unavailability for scheduled follow-up at the implanting center
- •Under guardianship
- •Age of less than 18 years.
结局指标
主要结局
VT/VF sensitivity
时间窗: 2 years
The primary purpose of this study is to evaluate the performance of the automatic detection of ventricular tachycardia and ventricular fibrillation (VT/VF) by the EventScope™ analyzer found in the Holter monitor SpiderFlash-t™. In order to validate this objective we will use the arrhythmia data collected in the memory storage found in the Sorin Group DR and CRT ICDs.
次要结局
- AF sensitivity(2 years)