VIenna Pilot Study for Automated Annular Suturing Technology (VIP-RAM)
Primary Purpose
Aortic Valve Disease, Mitral Valve Disease
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
automated annular suturing
Sponsored by
About this trial
This is an interventional other trial for Aortic Valve Disease focused on measuring surgical aortic valve replacement, surgical mitral valve replacement
Eligibility Criteria
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
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
surgical aortic valve replacement
surgical mitral valve replacement
Arm Description
n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement
n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Surgical times assessed by surgical report.
Surgical times, aortic cross-clamp time and cardiopulmonary-bypass time, assessed by surgical report.
Full Information
NCT ID
NCT04659655
First Posted
November 16, 2020
Last Updated
December 2, 2020
Sponsor
Medical University of Vienna
Collaborators
LSI SOLUTIONS, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04659655
Brief Title
VIenna Pilot Study for Automated Annular Suturing Technology
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
LSI SOLUTIONS, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Mitral Valve Disease
Keywords
surgical aortic valve replacement, surgical mitral valve replacement
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
surgical aortic valve replacement
Arm Type
Other
Arm Description
n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement
Arm Title
surgical mitral valve replacement
Arm Type
Other
Arm Description
n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement
Intervention Type
Procedure
Intervention Name(s)
automated annular suturing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freedom from mortality at 30 days post-OP assessed by clinical follow-up reports.
Description
Follow-ups 30 days post-OP are performed and freedom from mortality evaluated.
Time Frame
30 days post surgical valve replacement
Title
Implantation time assessed by surgical report.
Description
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.
Time Frame
procedural
Secondary Outcome Measure Information:
Title
Freedom from severe adverse events at 30 days post-OP assessed by clinical follow-up reports
Description
Follow-ups 30 days post-OP are performed to and freedom from severe adverse events evaluated.
Time Frame
30 days post surgical valve replacement
Title
Surgical times assessed by surgical report.
Description
Surgical times, aortic cross-clamp time and cardiopulmonary-bypass time, assessed by surgical report.
Time Frame
procedural
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Andreas, Assoc. Prof. PD MD MBA, PhD,
Phone
+43 1 40400 52620
Email
martin.andreas@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Werner, MD
Phone
+43 1 40400
Ext
- 47031
Email
paul.werner@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Andreas, Assoc. Prof. PD MD MBA, PhD,
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Andreas, MD, PhD
Phone
+4314040069660
Email
martin.andreas@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Paul Werner, MD
Phone
+43 (0)1 40400 - 47031
Email
paul.werner@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29174775
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.
Results Reference
background
PubMed Identifier
29552521
Citation
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.
Results Reference
background
PubMed Identifier
30070778
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.
Results Reference
background
PubMed Identifier
30540590
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.
Results Reference
background
Links:
URL
https://www.meduniwien.ac.at/hp/herzchirurgie/wissenschaft-forschung/working-group-applied-research-in-cardiac-surgery/
Description
Applied Research in Cardiac Surgery, Medical University of Vienna
URL
https://www.lsisolutions.com/
Description
LSI SOLUTIONS, Inc.
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VIenna Pilot Study for Automated Annular Suturing Technology
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