Abbott Structural Heart Device Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 36
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.
详细描述
The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes:
- Amplatzer portion: within 7 days post-procedure
- Cardiac Surgery portion (The ENDURE Study): within 6 months post-procedure.
All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years.
The Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed.
Follow-up visits should align with the site's routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.
- •Subject is willing and able to comply with the site's standard of care follow-up schedule.
- •Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.
排除标准
- •1. Subject is participating in another clinical study that would affect the results of this Registry.
研究组 & 干预措施
Cardiac Surgery (The ENDURE Study)
Approximately 1,800 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years. The minimum required sample sizes for each THV model are listed below. Approximately N=100 Epic Max enrollments will occur in the United States. A combined total of approximately N=1000 subjects will be enrolled globally across the Epic Elite (aortic and mitral) and Epic Supra G3 models.
- Approximately 225 subjects receiving Epic Plus mitral valves
- Approximately 225 subjects receiving Epic Elite mitral valves
- Approximately 150 subjects receiving Epic Plus aortic valves
- Approximately 170 subjects receiving Epic Plus Supra aortic valves
- Approximately 170 subjects receiving Epic Supra G3 aortic valves
- Approximately 285 subjects receiving Epic Max aortic valves
- Approximately 285 subjects receiving Epic Elite aortic valves
干预措施: Epic™ Surgical Tissue Heart Valve devices (Device)
Amplatzer
- ASO: ≥50 cases/year
- ASD-MF: ≥50 cases/year
- ADO: ≥50 cases/year
- ADO II: ≥50 cases/year
- Piccolo: ≥50 cases/year
- MuVSD: Up to 50 cases/year
- PI-VSD: Up to 50 cases/year
- Talisman/TDS: ≥100 cases/year
- TorqVue Delivery Systems Group 1 (ATV/ITV/EITV/TV2): 250 cases/year across different occluders
- TorqVue Delivery Systems Group 2 (TVLP/TVLPC): 100 cases/year across different occluders
- Piccolo Delivery System (PDS): 50 cases total
- SB II:100 PFO cases/year & 100 ASD cases/year
- GW: 200 cases/year
干预措施: Amplatzer™ Occlusion Devices (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 7 days
The primary safety endpoint will be the proportion of subjects with device- and/or procedure-related serious adverse events (SAEs) occurring within 7 days of the procedure.
Primary Effectiveness Endpoint
时间窗: Baseline
The primary effectiveness endpoint will be the proportion of procedures that achieved technical success, defined as completion of the procedure with an applicable Abbott SH device implanted
次要结局
未报告次要终点