Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement procedure. Participants will complete several neurocognitive assessments and an MRI procedure
| Condition(s) | Aortic Stenosis |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement procedure. Participants will complete several neurocognitive assessments and an MRI procedure. |
| Who can participate | Inclusion Criteria: criteria: 1. Age ≥ 22 years. 2. The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access. 3. Montreal Cognitive Assessment (MoCA) score ≥ 26 at screening. 4. The patient is willing and able to comply with protocol-specified follow-up evaluations. 5. The patient or legally authorized representative is able and willing to provide written informed consent. Exclusion Criteria: 1. Contraindications to MRI (e.g., subjects with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure, or claustrophobia). 2. Severe peripheral arterial, abdominal aortic, or |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | EnCompass Technologies, Inc. |
| Locations | Tbilisi, Georgia |
| Start date | 2023-04-29 |
| NCT ID | NCT05866640 |
| Official listing | https://clinicaltrials.gov/study/NCT05866640 |