MedTrace Logo

VIenna Pilot Study for Automated Annular Suturing Technology

NCT04659655 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-09

No results posted yet for this study

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.

Conditions

  • Aortic Valve Disease
  • Mitral Valve Disease

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • LSI SOLUTIONS, Inc.

    collaborator UNKNOWN

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Martin Andreas, Assoc. Prof. PD MD MBA, PhD, · Medical University of Vienna

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-01-01
Completion
2022-03-01
FDA Device
Yes

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659655 on ClinicalTrials.gov