NCT04659655

VIenna Pilot Study for Automated Annular Suturing Technology

VIenna Pilot Study for Automated Annular Suturing Technology to Assist in Aortic & Mitral Valve Replacement - A Single-center Clinical Safety & Feasibility Pilot Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology. In addition, data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.

Detailed description

This study is a clinical, single-center pilot-study to evaluate safety and performance. 30 Patients (n=20 aortic valve replacement/ n=10 mitral valve replacement) with aortic and mitral valve pathology, highly likely for prosthetic valve replacement, who are planned for surgery at the Vienna General Hospital (AKH) will be included in this study with respect to the inclusion and exclusion criteria. The patients will undergo aortic or prosthetic mitral valve replacement using a specified automated annular suturing system for placement of the annular pledgeted sutures.

Conditions

• Aortic Valve Disease
• Mitral Valve Disease

Interventions

Type	Name	Description
PROCEDURE	automated annular suturing	RAM® Automated Suturing Technology. The RAM® DEVICE and SEW-EASY® DEVICE are automated suturing devices indicated for use in the approximation of soft tissue and prosthetic materials when used in conjunction with RAM® COR-SUTURE® QUICK LOAD® surgical suture. Devices will be used for the approximation of respective replacement valves during surgical aortic or mitral valve replacement as described in the study protocol. Cases may include use of the RAM® RING/RAM® RACK devices for suture management and the Aortic Root Retractor (ARR) with delivery device.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-01
• Completion: 2022-03-01
• First posted: 2020-12-09
• Last updated: 2020-12-09

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study