NCT02933619已完成不适用
ProMRI ICD/CRT-D Post Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24,249
- 主要终点
- Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.
研究概览
简要总结
Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.
排除标准
- 未提供
结局指标
主要结局
Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.
时间窗: Up to 5 years post-approval
Primary objectives will be analyzed once 25 subjects implanted with the ProMRI ICD system have been identified with a documented true VF episode post-MRI.
Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.
时间窗: Up to 5 years post-approval
次要结局
- Left ventricular sensing attenuation(Up to 5 years post-approval)
- Workflow compliance following MR exposure(Up to 5 years post-approval)
研究者
相似试验
已完成
不适用
ProMRI Study of the Iforia ICD System (Phase C)Implantable Cardioverter-Defibrillator With Magnetic Resonance ImagingNCT02096692Biotronik, Inc.154
已完成
4 期
Primovist enhanced MRI for the detection and evaluation of focal liver lesionsfocal liver lesionfocal liver tumor10019815NL-OMON36761niversitair Medisch Centrum Utrecht230
撤回
4 期
Primovist enhanced MRI for the detection and evaluation of focal liver lesionsfocal liver lesionfocal liver tumor10019815NL-OMON33584niversitair Medisch Centrum Utrecht125
进行中（未招募）
不适用
Primovist enhanced MRI for the detection and evaluation of focal liver lesions - PRIDE-studyAll benign and malignant focal liver lesions e.g. colorectal liver metastases, HCC, haemangioma, adenoma, cysts, FNH.MedDRA version: 12.0Level: LLTClassification code 10024658Term: Liver carcinomaMedDRA version: 12.0Level: LLTClassification code 10027479Term: Metastatic liver carcinomaMedDRA version: 12.0Level: LLTClassification code 10019827Term: Hepatocellular adenomaMedDRA version: 12.0Level: LLTClassification code 10049010Term: Carcinoma hepatocellularMedDRA version: 12.0Level: LLTClassification code 10019396Term: Hemangioma of liverMedDRA version: 12.0Level: LLTClassification code 10048834Term: Polycystic liver diseaseMedDRA version: 12.0Level: LLTClassification code 10052285Term: Focal nodular hyperplasiaEUCTR2009-012115-18-NLMC Utrecht
招募中
不适用
PRIDE-study.focal liver lesionsNL-OMON24607Dr. R. van Hillegersberg, SurgeonCoordinating Investigator/Project leader/Principal Investigator:University Medical Center UtrechtHeidelberglaan 100, 3584 CX Utrecht,The Netherlands230