VIenna Pilot Study for Automated Annular Suturing Technology

Aortic Valve Disease Clinical Trial

— VIP-RAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04659655
• Other study ID #: EC 1660/2019
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: December 2020
• Source: Medical University of Vienna
• Contact: Martin Andreas, Assoc. Prof. PD MD MBA, PhD,
• Phone: +43 1 40400 52620
• Email: martin.andreas[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Mitral Valve Disease

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	LSI SOLUTIONS, Inc.

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Surgical times assessed by surgical report.	Surgical times, aortic cross-clamp time and cardiopulmonary-bypass time, assessed by surgical report.	procedural

External Links

•   Applied Research in Cardiac Surgery, Medical University of Vienna
•   LSI SOLUTIONS, Inc.