VIenna Pilot Study for Automated Annular Suturing Technology
VIP-RAM
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
December 9, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedDecember 9, 2020
December 1, 2020
1 year
November 16, 2020
December 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Freedom from severe adverse events at 30 days post-OP assessed by clinical follow-up reports
30 days post surgical valve replacement
Surgical times assessed by surgical report.
procedural
Study Arms (2)
surgical aortic valve replacement
OTHERn=20 patients with aortic valve pathology and indication for surgical aortic valve replacement
surgical mitral valve replacement
OTHERn=10 patients with mitral valve pathology and indication for surgical mitral valve replacement
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Viennalead
- LSI SOLUTIONS, Inc.collaborator
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Related Publications (4)
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.
PMID: 29174775BACKGROUNDJohnson 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.
PMID: 29552521BACKGROUNDRobinson 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.
PMID: 30070778BACKGROUNDNellis 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.
PMID: 30540590BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Andreas, Assoc. Prof. PD MD MBA, PhD,
Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. PD MD MBA, PhD, MEBCTS
Study Record Dates
First Submitted
November 16, 2020
First Posted
December 9, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
March 1, 2022
Last Updated
December 9, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share