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

NCT ID: NCT04671758

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2022-03-30

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. 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.

Conditions

Pure Aortic Regurgitation

Keywords

pure AR; TAVI; Sapien 3

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

AR TAVI

The population consists in patients with severe symptomatic AR on native aortic valve who are candidates for surgical aortic valve replacement but who are deemed inoperable by the heart team due to technical issues (i.e., porcelain aorta, previous coronary artery bypass grafting,…), extreme left ventricular dysfunction or comorbidities (liver cirrhosis, severe chronic obstructive pulmonary disease…).

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique Himbert, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Bichat Claude Bernard

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Dominique Himbert, MD

Role: CONTACT

Phone: 33140256601

Email: dominique.himbert@aphp.fr

Marina Urena, MD

Role: CONTACT

Phone: 33140256601

Email: marina.urena-alcazar@aphp.fr

Facility Contacts

Dominique Himbert, MD

Role: primary

Marina Urena, MD

Role: backup

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 27712786 (View on PubMed)

Other Identifiers

NI7005J

Identifier Type: -

Identifier Source: org_study_id