Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation

Pure Aortic Regurgitation Clinical Trial

— S3AR  

Official title:

Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation. The S3AR Study TAVI With Sapien 3 for Pure AR.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04671758
• Other study ID #: NI7005J
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: March 30, 2022

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Dominique Himbert, MD
• Phone: 33140256601
• Email: dominique.himbert[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The hypothesis is that TAVI using a SAPIEN 3 THV is feasible and safe for the treatment of pure AR.

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. Nonetheless, several cases report have suggested the feasibility of TAVI using the SAPIEN XT THV, in patients with no calcified valves suggesting that an appropriate degree of oversizing might compensate the lack of calcium for the anchoring of these prostheses.

The new generation balloon-expandable SAPIEN 3 THV has incorporated changes in the stent frame geometry, leaflets configuration and an external sealing skirt resulting in an increased stability and outstanding control during its implantation, a greater radial force, a reduced rate of paravalvular leaks and a covering of a wider range of annulus dimensions. These characteristics of the SAPIEN 3 THV might translate into a safer use of this device in patients with pure AR and non-calcified valves.

Significant AR occurs in 2.0% of individuals of >75 years, 13.3% of patients referred for intervention, being severe in 5% of these patients. As for aortic stenosis, its prevalence increases with age and the most frequent cause is degenerative although rheumatic and endocarditis are present. Although patients with severe AR have an excess risk of mortality and aortic valve replacement reduces mortality, only 1/3 of patients with significant AR finally undergo intervention. Reasons for no intervention are unknown.

Even if it has been suggested that AR might be underestimated and the prevalence of this disease might be higher than previously reported, and a percent of patients with indication for aortic valve replacement are denied for surgery, pure AR is a small niche of patients for TAVI. In terms of cost-effectiveness, both the development of a dedicated device and the investment in the training of operators in the implantation technique might lack of interest. However, performing TAVI with a device used in the routine practice might be appealing and, importantly, safer. A preliminary case series including 3 patients have suggested the feasibility of TAVI with the SAPIEN 3 device for pure AR (Urena M, Himbert D. JACC, 2016 ). In this study we aim to evaluate the feasibility and long-term safety of the SAPIEN 3 THV in patients with pure AR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Contraindication for TAVI (active endocarditis, aortic dissection, annuloectasia..)

• Patients' refusal

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Pure Aortic Regurgitation

Locations

Country	Name	City	State
France	Bichat Claude Bernard	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Urena M, Himbert D, Ohlmann P, Capretti G, Goublaire C, Kindo M, Morel O, Ghodbane W, Iung B, Vahanian A. Transcatheter Aortic Valve Replacement to Treat Pure Aortic Regurgitation on Noncalcified Native Valves. J Am Coll Cardiol. 2016 Oct 11;68(15):1705-1706. doi: 10.1016/j.jacc.2016.07.746. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and 30-day safety of TAVI with the SAPIEN 3 THV in patients with pure AR	1/ Device success at 1 month follow up according to the Valve Academic Research Consortium (VARC)-2. 2-Rate of moderate or severe AR at 1-month follow-up	30 days
Secondary	Long-term safety of TAVI with the SAPIEN 3 THV in patients with pure AR	Long-term safety defined as lack of valve migration and 1 year cardiovascular mortality defined according to the VARC-2 (combined endpoint)	1 year
Secondary	Long-term performance of TAVI with the SAPIEN 3 THV in patients with pure AR	Rate of moderate or severe AR at 1-year follow-up	1 year
Secondary	Long-term safety of TAVI with the SAPIEN 3 THV in patients with pure AR	Long-term safety defined as lack of 1-year all cause mortality	1 year