Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation (S3AR)

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

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

Study Overview

• Status: Unknown
• Conditions: Pure Aortic Regurgitation

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Dominique Himbert, MD; Phone Number: 33140256601; Email: dominique.himbert@aphp.fr
• Study Contact Backup: Name: Marina Urena, MD; Phone Number: 33140256601; Email: marina.urena-alcazar@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75018
      • Recruiting
      • Bichat Claude Bernard
      • Contact: Dominique Himbert, MD; Phone Number: 33 1 40 25 66 01; Email: dominique.himbert@aphp.fr
      • Contact: Marina Urena, MD; Phone Number: 33 1 40 25 66 01; Email: marina.urena-alcazar@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic (at least dyspnoea NYHA class III or acute heart failure requiring hospitalisation) and pure AR

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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…).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Dominique Himbert, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: TAVI; Sapien 3; pure AR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: NI7005J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No