Using Pulse Counter Vigileo-Flotrac System in Transapical Off-pump Minimally Invasive Mitral Valve Repair

April 21, 2018 updated by: Havva Sayhan, Sakarya University

Hemodynamic Monitorization Using Pulse Counter Vigileo-Flotrac Cardiac Output System in Transapical Off-pump Minimally Invasive Mitral Valve Repair

Minimally invasive transapical off-pump chordae implantation includes features such as tachycardia, arrhythmia, hemorrhage, sudden hemodynamic changes caused by the device moving in the left ventricle and the atrium, for anesthetists. In this observational study, the investigators presented the investigators's hemodynamic recuperation and anesthesia experiences revealed by cardiac output measurement after transapical mitral valve repair.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In Sakarya University Educational Research Hospital, perioperative file records of 13 patients who underwent mitral valve repair using the Neochord DS1000 system were retrospectively analyzed. In addition, hemodynamic measurements recorded with the Vigileo Flotrac invasive arterial cardiac output device were evaluated.

Study Type

Observational

Enrollment (Anticipated)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Sakarya, Merkez, Turkey, 54100
        • Recruiting
        • Sakarya University Research and Training hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 patients who underwent mitral valve repair with Neochord DS1000 system after severe mitral insufficiency in Sakarya University Educational Research Hospital between September-2016 and June-2017

Description

Inclusion Criteria:

  • All patients that surgical criteria for Neochord implantation with transapical mini-thoracotomy are prolapsus or chordae rupture in posterior, anterior areas or in both leaflets were included.

Exclusion Criteria:

  • Exclusion criteria are active endocarditis, functional or ischemic mitral insufficiency (MI), excessive calcific valves, leaflet perforation, anemic dilatation and severe left ventricular dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mitral valve prolaps
Hemodynamic recovery and anesthesia revealed by invasive arterial cardiac output (CO) measurement (Vigileo Flo-trac device) in 13 cases who underwent mitral valve (MV) repair with the transapical off-pump minimally invasive method in our clinic.
Device: Vigileo Flo-trac device
A Vigileo Flotrac pulse counter invasive arterial cardiac output meter was used for cardiac output measurement. Heart rate, blood pressure, cardiac output, stroke volume variance (SVV), systemic vascular resistance (SVR) values were recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
invasive arterial cardiac output (CO) measurement
Time Frame: 1 month
A Vigileo Flotrac pulse counter invasive arterial cardiac output meter was used for cardiac output measurement.
1 month
systemic vascular resistance (SVR)
Time Frame: 1mounth
Systemic vascular resistance is used in calculations of blood pressure, blood flow, and cardiac function. Vasoconstriction (i.e., decrease in blood vessel diameter) increases SVR, whereas vasodilation (increase in diameter) decreases SVR
1mounth
stroke volume variance (SVV)
Time Frame: 1 mounth
Stroke volume variation is a naturally occurring phenomenon in which the arterial pulse pressure falls during inspiration and rises during expiration due to changes in intra-thoracic pressure secondary to negative pressure ventilation (spontaneously breathing).
1 mounth
blood pressure
Time Frame: 1 mounth
The first (or top) number is your systolic blood pressure. It is the highest level your blood pressure reaches when your heart beats. The second (or bottom) number is your diastolic blood pressure. It is the lowest level your blood pressure reaches as your heart relaxes between beats.
1 mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Investigators

  • Study Chair: Umit Karadeniz, Sakarya University Research and Training hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 21, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 21, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • neocorda

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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