VIenna Pilot Study for Automated Annular Suturing Technology

Not Applicable

• Conditions: Aortic Valve Disease; Mitral Valve Disease
• Interventions: Procedure: automated annular suturing

• Registration Number: NCT04659655
• Lead Sponsor: Medical University of Vienna

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-16
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Study First Posted: 2020-12-09
• Last Update Posted: 2020-12-09
• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with low to moderate operative risk (Defined by STS mortality risk below 8%)
• Patients above the age of 18 years
• Patients willing and able to sign the informed consent

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Exclusion Criteria

• Patients with active endocarditis
• Patients with previous cardiac surgery other than pacemaker implantation
• Emergency procedures
• Patient who did not sign the informed consent form and/ or refuse to participate
• Patients unable to read or understand the informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
surgical mitral valve replacement	automated annular suturing	n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement
surgical aortic valve replacement	automated annular suturing	n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement

Primary Outcome Measures

Name	Time	Method
Freedom from mortality at 30 days post-OP assessed by clinical follow-up reports.	30 days post surgical valve replacement	Follow-ups 30 days post-OP are performed and freedom from mortality evaluated.
Implantation time assessed by surgical report.	procedural	Implantation time, the duration defined from start of the valve assessment until the completion of the prosthesis implantation (defined as fixation of the last suture) assessed by surgical report.

Secondary Outcome Measures

Name	Time	Method
Surgical times assessed by surgical report.	procedural	Surgical times, aortic cross-clamp time and cardiopulmonary-bypass time, assessed by surgical report.
Freedom from severe adverse events at 30 days post-OP assessed by clinical follow-up reports	30 days post surgical valve replacement	Follow-ups 30 days post-OP are performed to and freedom from severe adverse events evaluated.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria