SHIELD – Dr Karl Poon
The objective of the SHIELD clinical trial is to evaluate the safety and performance of the F2 Filter and Delivery System in preventing embolic material from travelling to the brain during transcatheter aortic valve replacement (TAVR) .
Research Objectives
Status
Recruitment
Total participants required
Study location
Study type
Patient group
About this clinical trial
People undergoing TAVR are at risk of small blood clots or debris travelling to the brain during the procedure, which can lead to stroke or mini-stroke (TIA). The SHIELD study is evaluating an investigational device called the EnCompass F2 Filter and Delivery System, which is designed to protect all three major blood vessels that supply blood to the brain during TAVR.
Participants in this study will be randomly assigned to receive either the F2 cerebral protection device during their TAVR procedure or standard care, which may include no embolic protection or use of an approved protection device, depending on usual hospital practice. Most tests and assessments involved in the study are part of routine care for patients having TAVR.
The study will assess the safety of the device and how well it performs in preventing debris from reaching the brain. Participants will be followed for up to 30 days after the procedure, with additional follow-up if stroke symptoms occur. Participation is voluntary, and choosing not to take part will not affect standard medical care.
Trial Information – https://www.clinicaltrials.gov/study/NCT06689839
Eligibility
Self-screening is not recommended for this study. Eligibility will be confirmed by the study doctor based on medical history, imaging results, and clinical assessment.
Lead investigator
- Dr Karl Poon
Clinical trial coordinator
- Linda Pearce
Technical title
A Prospective, Randomized, Multicenter, Single-Blind Trial to Assess the Safety and Effectiveness of the EnCompass F2 Cerebral Protection System vs. Standard of Care (unprotected or Sentinel® Cerebral Protection System) during Transfemoral Transcatheter Aortic Valve Replacement (TF TAVR)