VIenna Pilot Study for Automated Annular Suturing Technology (VIP-RAM)

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

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Disease; Mitral Valve Disease
• Intervention / Treatment: Procedure: automated annular suturing

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Andreas, Assoc. Prof. PD MD MBA, PhD,; Phone Number: +43 1 40400 52620; Email: martin.andreas@meduniwien.ac.at
• Study Contact Backup: Name: Paul Werner, MD; Phone Number: - 47031 +43 1 40400; Email: paul.werner@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Martin Andreas, MD, PhD; Phone Number: +4314040069660; Email: martin.andreas@meduniwien.ac.at
    • Contact: Paul Werner, MD; Phone Number: +43 (0)1 40400 - 47031; Email: paul.werner@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: surgical aortic valve replacement; n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement	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.
Other: surgical mitral valve replacement; n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: LSI SOLUTIONS, Inc.
• Investigators: Principal Investigator: Martin Andreas, Assoc. Prof. PD MD MBA, PhD,, Medical University of Vienna

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: surgical aortic valve replacement; surgical mitral valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: EC 1660/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes