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| Name | Class |
|---|---|
| LSI SOLUTIONS, Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgical aortic valve replacement | Other | n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement |
|
| surgical mitral valve replacement | Other | n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| automated annular suturing | Procedure | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Andreas, Assoc. Prof. PD MD MBA, PhD, | Contact | +43 1 40400 52620 | martin.andreas@meduniwien.ac.at | |
| Paul Werner, MD | Contact | +43 1 40400 | - 47031 | paul.werner@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Martin Andreas, Assoc. Prof. PD MD MBA, PhD, | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29174775 | Background | Wong JK, Melvin AL, Siordia JA, Joshi DJ, Sauer JS, Knight PA. Novel Automated Suturing Technology for Minimally Invasive Aortic Valve Replacements. Ann Thorac Surg. 2018 Feb;105(2):645-649. doi: 10.1016/j.athoracsur.2017.07.054. Epub 2017 Nov 27. | |
| 29552521 | Background | Johnson CA Jr, Melvin AL, Lebow BF, Yap A, Knight PA. Video assisted right mini-thoracotomy for aortic valve replacement. J Vis Surg. 2018 Feb 27;4:39. doi: 10.21037/jovs.2018.01.16. eCollection 2018. |
| Label | URL |
|---|---|
| LSI SOLUTIONS, Inc. | View source |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
Surgical times, aortic cross-clamp time and cardiopulmonary-bypass time, assessed by surgical report. |
| procedural |
| 30070778 | Background | Robinson DA, Sagebin F, Yap AJ, Johnson CA Jr, Knight PA. Aortic valve replacement with annular enlargement via a right anterior minithoracotomy. Multimed Man Cardiothorac Surg. 2018 Jul 26;2018. doi: 10.1510/mmcts.2018.044. |
| 30540590 | Background | Nellis JR, Fitch ZW, Choi AY, Meza JM, Spector ZZ, Von Bergen NH, Torres JE, Klapper JA, Sauer JS, Turek JW. A Minimally Invasive Approach for Placing Sew-On Epicardial Leads in the Child. Innovations (Phila). 2018 Nov/Dec;13(6):455-457. doi: 10.1097/IMI.0000000000000568. |