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VIenna Pilot Study for Automated Annular Suturing Technology

NCT ID: NCT04659655

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-03-01

Brief Summary

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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

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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

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Aortic Valve Disease Mitral Valve Disease

Keywords

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surgical aortic valve replacement surgical mitral valve replacement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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surgical aortic valve replacement

n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement

Group Type OTHER

automated annular suturing

Intervention Type PROCEDURE

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.

surgical mitral valve replacement

n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement

Group Type OTHER

automated annular suturing

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LSI SOLUTIONS, Inc.

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Martin Andreas, M.D.

Assoc. Prof. PD MD MBA, PhD, MEBCTS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Andreas, Assoc. Prof. PD MD MBA, PhD,

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Martin Andreas, Assoc. Prof. PD MD MBA, PhD,

Role: CONTACT

Phone: +43 1 40400 52620

Email: [email protected]

Paul Werner, MD

Role: CONTACT

Phone: +43 1 40400

Email: [email protected]

Facility Contacts

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Martin Andreas, MD, PhD

Role: primary

Paul Werner, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 29174775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29552521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30070778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30540590 (View on PubMed)

Related Links

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https://www.lsisolutions.com/

LSI SOLUTIONS, Inc.

Other Identifiers

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EC 1660/2019

Identifier Type: -

Identifier Source: org_study_id