Aortic Valve DiseaseVIP-RAMNCT04659655
VIenna Pilot Study for Automated Annular Suturing Technology
A study testing automated annular suturing in people with Aortic Valve Disease and Mitral Valve Disease, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Valve Disease, Mitral Valve Disease
- What is being tested?
- automated annular suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Martin Andreas, Assoc. Prof. PD MD MBA, PhD, contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Martin Andreas, MD, PhD, +4314040069660, martin.andreas@meduniwien.ac.at
Paul Werner, MD, +43 (0)1 40400 - 47031, paul.werner@meduniwien.ac.at
About this study
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
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.
Read the 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.
- Conditions
- Aortic Valve Disease, Mitral Valve Disease
- Being tested
- automated annular suturing
- Keywords
- surgical aortic valve replacement, surgical mitral valve replacement
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated annular suturingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| surgical aortic valve replacement | Other | n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement Receives: Procedure: automated annular suturing |
| surgical mitral valve replacement | Other | n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement Receives: Procedure: automated annular suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: procedural
Secondary outcomes (2)
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.
Measured: 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.
Measured: procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- LSI SOLUTIONS, Inc.
- Responsible party
- Principal investigator, Martin Andreas, M.D., Medical University of Vienna
- Investigators
- Martin Andreas, Assoc. Prof. PD MD MBA, PhD,, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659655
- Sponsor's protocol ID
- EC 1660/2019
- Acronym
- VIP-RAM
- Status last verified
- Dec 2020
- First submitted
- 16 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 29174775Johnson 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.
PubMed 29552521Robinson 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.
PubMed 30070778Nellis 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.
PubMed 30540590
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04659655
- Acronym / sponsor ID
- VIP-RAM / EC 1660/2019
- Conditions
- Aortic Valve Disease, Mitral Valve Disease
- Keywords
- surgical aortic valve replacement, surgical mitral valve replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- LSI SOLUTIONS, Inc.
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical aortic valve replacement | Other | Procedure: automated annular suturingn=20 patients with aortic valve pathology and indication for surgical aortic valve replacement |
| surgical mitral valve replacement | Other | Procedure: automated annular suturingn=10 patients with mitral valve pathology and indication for surgical mitral valve replacement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| automated annular suturingRAM® 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. | Procedure or surgery | surgical aortic valve replacement, surgical mitral valve replacement |
Primary outcome
Freedom from mortality at 30 days post-OP assessed by clinical follow-up reports.
Time frame: 30 days post surgical valve replacement
Follow-ups 30 days post-OP are performed and freedom from mortality evaluated.
Implantation time assessed by surgical report.
Time frame: procedural
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.
2 secondary outcomes
Freedom from severe adverse events at 30 days post-OP assessed by clinical follow-up reports
Time frame: 30 days post surgical valve replacement
Surgical times assessed by surgical report.
Time frame: procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Background: PubMed 29174775Wong 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.
- Background: PubMed 29552521Johnson 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.
- Background: PubMed 30070778Robinson 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.
- Background: PubMed 30540590Nellis 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.
- LSI SOLUTIONS, Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Andreas, Assoc. Prof. PD MD MBA, PhD, contact
Martin Andreas, Assoc. Prof. PD MD MBA, PhD, principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automated annular suturing in people with Aortic Valve Disease and Mitral Valve Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Andreas, Assoc. Prof. PD MD MBA, PhD, (+43 1 40400 52620, martin.andreas@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from mortality at 30 days post-OP assessed by clinical follow-up reports. (time frame: 30 days post surgical valve replacement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04659655, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.