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

Sponsor
Sakarya University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03506217
Collaborator
(none)
13
1
8
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vigileo Flo-trac device

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 Design

Study Type:
Observational
Anticipated Enrollment :
13 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Hemodynamic Monitorization Using Pulse Counter Vigileo-Flotrac Cardiac Output System in Transapical Off-pump Minimally Invasive Mitral Valve Repair
Anticipated Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. invasive arterial cardiac output (CO) measurement [1 month]

    A Vigileo Flotrac pulse counter invasive arterial cardiac output meter was used for cardiac output measurement.

  2. systemic vascular resistance (SVR) [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

  3. stroke volume variance (SVV) [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).

  4. blood pressure [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sakarya University Research and Training Hospital Sakarya Merkez Turkey 54100

Sponsors and Collaborators

  • Sakarya University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Havva Sayhan, Assistant Professor, Sakarya University
ClinicalTrials.gov Identifier:
NCT03506217
Other Study ID Numbers:
  • neocorda
First Posted:
Apr 24, 2018
Last Update Posted:
Apr 24, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Havva Sayhan, Assistant Professor, Sakarya University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 24, 2018