Assessment of Safety and Efficiency of the Medical Device Called PacePress to Prevent Hemorrhagic Complications in Patients With High Bleeding Risk Undergoing CIED Implantation Procedures in an Open-label, Multi-Centre Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 122
- 试验地点
- 13
- 主要终点
- Assessment of hematoma presence
研究概览
简要总结
PacePress medical device, by ensuring constant compression force and the ability to optimize it in the pocket area prevents/significantly reduces the risk of hemorrhagic complications, including but not limited to the operation pocket hematoma. By avoiding a strong localized compression and ensuring "covering compression" achieved by the appropriate distribution of compression forces on the entire implantation site area, with an automated compression force control, the risk of a pressure sore created in the compressed pocket area is reduced.
详细描述
The study will be an open-label, multi-center, monitored randomized study with 235 subjects qualified for:
- the CIED implantation procedure (initial),
- the CIED replacement procedure (ICD, CRT),
- expantion of the system,
- revision of electrodes.
The study consists in randomization of patients who meet all the inclusion criteria and do not meet any of the exclusion criteria, after performing the above procedure for the group (A): the PacePress medical device will be used, or (B): a standard of care will be used, in order to compare the safety and efficacy of the PacePress in relation to the standard of care, in preventing hemorrhagic complications and site infections.
Data regarding the assessment of the safety and effectiveness of the PacePress medical device are collected on the day of the procedure and during the 30-day patient observation.
In PacePress clinical trial, the standard pharmacotherapeutic procedures in the facility are not modified or affected (including but not limited to the anti-coagulation and antiplatelet treatment) according to the guidelines and standard procedure ESC and PTK in patients included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Age > 18 years.
- •The patient qualified for:
- •the CIED implantation procedure (initial),
- •the CIED replacement procedure (ICD, CRT),
- •expansion of the system,
- •revision of electrodes.
- •The patient standing high bleeding risk defined as a result of PACE DRAP ≥
- •The patient taking anti-coagulation or anti-platelet drugs or anti-coagulation and anti-platelet drugs permanently.
排除标准
- •The absence of written consent to participate in the study.
- •A female patient who is pregnant or breast-feeds.
- •The interview reveals addiction to alcohol, drugs, and other psychoactive substances.
- •The anamnesis reveals known hemorrhagic diathesis or thrombocytopenia, particularly after heparin is administered.
- •Active infection of the implantation site.
- •Active infection 4 weeks before inclusion in the study.
- •Anomaly in the chest near the device site.
- •The patient participates in another clinical trial.
- •Anticipated life span < 6 months.
- •Diagnosed allergy to any device ingredient.
- •The patient undergoes active biological therapy.
- •Treated cancer.
- •The patient undergoes shoulder girdle physiotherapy.
- •The patient undergoes systemic steroid therapy (intravenous therapy).
- •Obesity preventing the application of PacePress device.
- •Criteria excluding the patient from the study that may appear during or immediately after the procedure:
- •Cardiac arrest (CPR)
- •Perforation.
- •Pneumothorax.
- •Intubation (patient intubated after the procedure).
- •Change of pacemaker position (conversion to the right side).
- •Procedure completed without implantation of the intended system.
- •Need for invasive treatment of complications of the procedure.
结局指标
主要结局
Assessment of hematoma presence
时间窗: 7 (-0/+2) days after the procedure
according to the classification: Degree 0 - No hematoma Degree 1 - Hematoma not visible clinically - petechia above the device site (a tiny exudate or extravasation near the device, not causing any skin raising visible in a macroscopic scale), Degree 2 - Hematoma visible clinically - a visible macroscopically and palpable swelling of CIED area clearly exceeding the device dimensions, causing the tenderness and painfulness of the affected area; petechia going beyond the pocket, fluctuation symptom, small skin tension, small skin raising, Degree 3 - Hematoma significant clinically - much exceeding the device dimensions, causing significant skin tension and raising, requiring evacuation or extending hospital stay by at least 24 hours; pocket pain, significant skin raising.
次要结局
- Number of patients who need blood derivative transfusion(based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation)
- Mortality rate(based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation)
- Infection(based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation)
- Emergence of a hematoma(based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation)