Status:
UNKNOWN
Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pure Aortic Regurgitation
Eligibility:
All Genders
Brief Summary
The hypothesis is that TAVI using a SAPIEN 3 THV is feasible and safe for the treatment of pure AR.
Detailed Description
Up to now, the balloon-expandable valves have been considered contraindicated for patients with pure AR due to the absence of calcium which is considered necessary for the anchoring of the prosthesis....
Eligibility Criteria
Inclusion
- Patients with symptomatic (at least dyspnoea NYHA class III or acute heart failure requiring hospitalisation) and pure AR
- Contraindication or high risk for surgical aortic valve replacement
- Echocardiography and computed tomography findings suitable for TAVI using a SAPIEN 3 THV
Exclusion
- Contraindication for TAVI (active endocarditis, aortic dissection, annuloectasia..)
- Patients' refusal
Key Trial Info
Start Date :
June 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04671758
Start Date
June 1 2017
End Date
March 30 2022
Last Update
December 17 2020
Active Locations (1)
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1
Bichat Claude Bernard
Paris, Île-de-France Region, France, 75018