Aortic Valve Disease, Mitral Valve Disease
Conditions
Keywords
surgical aortic valve replacement, surgical mitral valve replacement
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.
Interventions
PROCEDUREautomated 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.
Sponsors
LSI SOLUTIONS, Inc.
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Surgical times assessed by surgical report. | procedural | Surgical times, aortic cross-clamp time and cardiopulmonary-bypass time, assessed by surgical report. |
Countries
Austria
Contacts
Primary ContactMartin Andreas, Assoc. Prof. PD MD MBA, PhD,
Backup ContactPaul Werner, MD
Outcome results
None listed