VIenna Pilot Study for Automated Annular Suturing Technology

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Valve Disease, Mitral Valve Disease

Intervention / Treatment
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* Procedure: automated annular suturing


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: surgical aortic valve replacement<br>n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement | Procedure: automated annular suturing<br>* 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.<br>|
| Other: surgical mitral valve replacement<br>n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement | Procedure: automated annular suturing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from mortality at 30 days post-OP assessed by clinical follow-up reports. | Follow-ups 30 days post-OP are performed and freedom from mortality evaluated. | 30 days post surgical valve replacement | 
| Implantation time assessed by surgical report. | 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. | procedural | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical aortic valve replacement, surgical mitral valve replacement