Clinical trial NCT04659655: VIenna Pilot Study for Automated Annular Suturing Technology
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
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Disease
Mitral Valve Disease
Keywords: surgical aortic valve replacement
surgical mitral valve replacement
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: LSI SOLUTIONS, Inc.
First posted: 2020-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Freedom from mortality at 30 days post-OP assessed by clinical follow-up reports.
timeFrame: 30 days post surgical valve replacement
measure: Implantation time assessed by surgical report.
timeFrame: procedural
Secondary outcomes:
measure: Freedom from severe adverse events at 30 days post-OP assessed by clinical follow-up reports
timeFrame: 30 days post surgical valve replacement
measure: Surgical times assessed by surgical report.
timeFrame: procedural
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Martin Andreas, Assoc. Prof. PD MD MBA, PhD,
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.