NCT07619872招募中不适用
KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance
Edwards Lifesciences1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年6月25日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
研究概览
简要总结
KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.
详细描述
Subjects in the KONECTION study will be enrolled at up to 20 sites in Europe and Canada. The population will be participants requiring replacement of their diseased native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years or older at the time of informed consent
- •Have a diseased native or prosthetic aortic valve and a damaged or diseased ascending aorta that requires aortic valved conduit replacement surgery with the KONECT RESILIA AVC
- •Provide written informed consent
- •Willing to follow protocol requirements
排除标准
- •Active endocarditis or endocarditis within 3 months prior to the study index procedure
- •Emergency procedure
- •Stage 4 renal disease (estimated glomerular filtration rate [eGFR] <30 excluded) or requiring dialysis
- •Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator
- •High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%
研究组 & 干预措施
Edwards KONECT RESILIA AVC
Subjects who were treated with the Edwards KONECT RESILIA AVC
干预措施: Edwards KONECT RESILIA AVC (Device)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
SVF-Treo Study: Influence of Cardiac and Respiratory Pulsatility DeformationAbdominal Aortic AneurysmNCT07475260University of Twente25
招募中
不适用
REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)NCT07462624Heart Center Leipzig - University Hospital890
尚未招募
2 期
A study to compare Aortocaval index and IVC collapsibility index for fluid administration in septic shock patientsCTRI/2024/10/075067Dr Harikrishnan S100
尚未招募
不适用
AVF-MONITOR POC Proof-of-concept StudyNCT07318025Mario Negri Institute for Pharmacological Research6
招募中
不适用
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVINCT07343674Portuguese Association of Interventional Cardiology500