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

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ClinicalTrials.gov Identifier: NCT03506217
Recruitment Status : Unknown
Verified April 2018 by Havva Sayhan, Sakarya University.
Recruitment status was:  Recruiting
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Havva Sayhan, Sakarya University

Study Description
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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
Mitral Valve Prolapse 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
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Study Type : Observational
Estimated 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
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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).

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506217


Contacts
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Contact: Havva Sayhan, Assis Prof +905056621021 hsayhan@gmail.com
Contact: Umit Karadeniz, prof +905326025264 ukaradeniz2003@gmail.com

Locations
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Turkey
Sakarya University Research and Training Hospital Recruiting
Sakarya, Merkez, Turkey, 54100
Contact: Havva Sayhan, Assis Prof    +905056621021    hsayhan@gmail.com   
Contact: umit Karadeniz    +905326025264    ukaradeniz2003@gmail.com   
Sponsors and Collaborators
Sakarya University
Investigators
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Study Chair: Umit Karadeniz Sakarya University Research and Training Hospital
More Information
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Publications of Results:

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Responsible Party: Havva Sayhan, Assistant Professor, Sakarya University
ClinicalTrials.gov Identifier: NCT03506217    
Other Study ID Numbers: neocorda
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Havva Sayhan, Sakarya University:
mitral valve prolaps,
chorda tendinea,
cardiac output
Additional relevant MeSH terms:
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Mitral Valve Prolapse
Prolapse
Pathological Conditions, Anatomical
Heart Valve Prolapse
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases