Clinical Study of a Novel Transcatheter Anti-embolic Filter for Cerebral Protection During Aortic Valve Interventions
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Valve Stenosis
- Intracranial Embolism and Thrombosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
A single arm, prospective, multicenter non-randomized clinical study of the AorticLab TAF System to prevent embolic complications during transcatheter aortic valve procedures. Forty participants will be enrolled at up to six sites in Europe and will undergo clinical follow-up at 24hrs ± 8hrs post-pr...
A single arm, prospective, multicenter non-randomized clinical study of the AorticLab TAF System to prevent embolic complications during transcatheter aortic valve procedures. Forty participants will be enrolled at up to six sites in Europe and will undergo clinical follow-up at 24hrs ± 8hrs post-procedure, discharge or 7 days, whichever comes first and 30 days.
Tracking Information
- NCT #
- NCT04704258
- Collaborators
- Not Provided
- Investigators
- Study Chair: Franco Osta AorticLab Srl
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