TAV-in-SAV in Japanese Patients

NCT06826027 | Active Not Recruiting

• 1 other identifier: TAV-in-SAV in Japan
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 10

Brief Summary

Background In 2018, transcatheter aortic valve in surgical aortic valve (TAV-in-SAV) in high risk patients was approved for the treatment of bioprosthetic valve dysfunction due to aging, for which valve replacement had been selected. It has been reported that early and mid-term results of TAV-in-SAV differ depending on the sizes of the original surgical bioprosthetic valves. Especially, the prognoses of TAV-in-SAV in patients with surgical bioprosthetic valves of ≤21 mm in size are reported to be poor in the United States and Europe. Bioprosthetic valves of ≥21 mm in size are thus tended to be used also in Japan after the annular was enlarged in the initial surgery as needed. The patient group in the above-mentioned report, however, consisted of larger patients (with the mean body surface area of 1.85 m2). It has therefore been unknown whether the above report applies to smaller patients in Japan. Furthermore, in terms of the surgical results for valvular disease, not only short-term results, but also repeat surgery avoidance rate, as well as medium- and long-term results, including the occurrence rate of complications related to artificial valves, are important factors, but the characteristic of this disease, the number of cases at each facility is not that large, so there have been no comprehensive reports of TAV-in-SAV in Japan. Accordingly, the investigators will investigate TAV-in-SAV performed at Osaka University as well as multiple centers in Japan to: understand the facts; assess the appropriateness of the evaluation of the above-mentioned paper; and examine early and mid-term treatment results of TAV-in-SAV in patients with narrow bioprosthetic valves, which are specific to Japanese patients. The investigators also plan to study early and mid-term treatment results of TAV-in-SAV using a self-expanding valve because self-expanding valves generally produce favorable hemodynamics in narrow bioprosthetic valves. Study Objectives i. To study early and mid-term results of transcatheter aortic valve implantation in patients with aortic bioprosthetic valve dysfunction (hereinafter referred to as TAV-in-SAV). ii. To compare clinical results, including hemodynamics, of TAV-in-SAV between small aortic bioprosthetic valves (19 or 21 mm in size) and aortic bioprosthetic valves of other sizes. iii. To compare clinical results, including hemodynamics, of TAV-in-SAV between a self-expanding valve and a balloon-expandable valve. Study Methods i. Study design A multicenter, retrospective, observational study using existing data. ii. Endpoints Study endpoints are as follows: Primary endpoint: Death during the observation period The mortality among all patients registered in this study will be estimated with the Kaplan-Meier method. Secondary endpoints: Analyses of major cardiac and cerebral events (MACCE) and factors associated with death. The rate of freedom from MACCE among all patients registered in this study will be estimated with the Kaplan-Meier method. Factors associated with death will be explored using a Cox proportional hazards model. Hemodynamics and events including death and MACCE will also be compared between aortic bioprosthetic valves of 19 or 21 mm in size and those of other sizes. In addition, hemodynamics and events including death and MACCE will be compared between a self-expanding valve (Evolut) and a balloon-expandable valve (SAPIEN) using propensity-matching analyses.

Conditions

Valve-in-valve Procedures

Outcome Measures

Primary Outcomes (1)

• Death during the observation period

  through study completion, an average of 2 year

Secondary Outcomes (1)

• freedom from MACCE

  through study completion, an average of 2 year

Study Arms (1)

TAV-in-SAV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include patients who underwent TAV-in-SAV at the Osaka University Hospital or any of the following study centers between January 1, 2013 and March 31, 2023.

You may qualify if:

• This study will include patients who underwent TAV-in-SAV at the Osaka University Hospital or any of the following study centers between January 1, 2013 and March 31, 2023.

You may not qualify if:

• Study subjects who or whose legally accepted representatives refuse to participate in or to continue to be in the study.

Sponsors & Collaborators

• Osaka University: lead
• Medtronics, Inc.: collaborator

Study Sites (10)

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, 2790001, Japan

Location

Kyusyu University

Fukuoka, Fukuoka, 8128582, Japan

Location

Kurume University

Kurume, Kurume, 8300011, Japan

Location

The Skakibara Heart Institute of Okayama

Okayama, Okayama-ken, 7000804, Japan

Location

Osaka International Medical and Science Center

Osaka, Osaka, 5438922, Japan

Location

Osaka University

Suita, Osaka, 5650871, Japan

Location

Saga University

Saga, Saga-ken, 8498501, Japan

Location

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, 3438555, Japan

Location

Tokyo Women's Medical University

Shinjuku, Tokyo, 1628666, Japan

Location

Tottori University

Yonago, Tottori, 6838504, Japan

Location

Related Publications (1)

• Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, Barbanti M, Latib A, Schaefer U, Rodes-Cabau J, Treede H, Piazza N, Hildick-Smith D, Himbert D, Walther T, Hengstenberg C, Nissen H, Bekeredjian R, Presbitero P, Ferrari E, Segev A, de Weger A, Windecker S, Moat NE, Napodano M, Wilbring M, Cerillo AG, Brecker S, Tchetche D, Lefevre T, De Marco F, Fiorina C, Petronio AS, Teles RC, Testa L, Laborde JC, Leon MB, Kornowski R; Valve-in-Valve International Data Registry Investigators. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA. 2014 Jul;312(2):162-70. doi: 10.1001/jama.2014.7246.

  PMID: 25005653 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: February 13, 2025
• Study Start: August 7, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)