Skip to main content
Clinical Trials/NCT03506217
NCT03506217
Unknown
Not Applicable

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

Sakarya University1 site in 1 country13 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Valve Prolapse
Sponsor
Sakarya University
Enrollment
13
Locations
1
Primary Endpoint
invasive arterial cardiac output (CO) measurement
Last Updated
8 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
January 1, 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sakarya University
Responsible Party
Principal Investigator
Principal Investigator

Havva Sayhan

Assistant Professor

Sakarya University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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

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).

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.

Study Sites (1)

Loading locations...

Similar Trials