The role of cerebral embolic protection in preventing strokes and improving other health outcomes in patients receiving a replacement heart valve
- Conditions
- Aortic stenosisCirculatory System
- Registration Number
- ISRCTN16665769
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 7730
Current inclusion criteria as of 04/11/2021:
1. Participant is willing and able to give informed consent for participation in the trial
2. Aged 18 years or above
3. Considered to be candidates for TAVI by the clinical team (via any access route where CEP may be used)
4. Participant is suitable for treatment with the cerebral embolic protection device in the opinion of the treating physician
Previous inclusion criteria:
1. Willing and able to give informed consent for participation in the trial.
2. Aged 18 years or above
3. Diagnosed with aortic stenosis (including bioprosthetic valve dysfunction)
4. Planned transfemoral TAVI
Current exclusion criteria as of 04/11/2021:
No specific exclusion criteria.
Participants involved in observational studies will be eligible for this study. As this is an all-comer design, current or previous participation in other ongoing randomised trials will not be disqualifying for recruitment to this study unless treatment is expected to impact the effect of using a CEP device on stroke.
Previous exclusion criteria:
1. Anatomically unsuitable for treatment with the cerebral embolic protection device in the opinion of the treating physician
2. Clinical contra-indications to the use of the CEP device in the opinion of the treating physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method