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Status unknownNCT03506217Updated Apr 24, 2018

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

An observational study in Mitral Valve Prolapse, sponsored by Sakarya University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-24.

Sponsored by Sakarya University · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
13
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Mitral Valve Prolapse

Keywords

  • mitral valve prolaps,
  • chorda tendinea,
  • cardiac output
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In context

Mitral Valve Prolapse

41 studies on the registry are indexed under Mitral Valve Prolapse; 13 are open to participants now.

This study's planned enrollment of 13 is below the median of 150 across 23 observational studies indexed under Mitral Valve Prolapse.

Browse Mitral Valve Prolapse studies →

Lead sponsor

Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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:

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

Observational model
Other
Time perspective
Retrospective
Enrollment
13 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceVigileo 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.

06

What researchers measure

Primary outcomes

  1. invasive arterial cardiac output (CO) measurement

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

    Time frame: 1 month

  2. systemic vascular resistance (SVR)

    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

    Time frame: 1mounth

  3. stroke volume variance (SVV)

    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).

    Time frame: 1 mounth

  4. blood pressure

    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.

    Time frame: 1 mounth

07

Study locations

1 of 1 sites recruiting
  • Sakarya University Research and Training Hospital
    Sakarya, Merkez 54100, Turkey
    Recruiting
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References and documents

Publications

  • Colli A, Zucchetta F, Torregrossa G, Manzan E, Bizzotto E, Besola L, Bellu R, Sarais C, Pittarello D, Gerosa G. Transapical off-pump mitral valve repair with Neochord Implantation (TOP-MINI): step-by-step guide. Ann Cardiothorac Surg. 2015 May;4(3):295-7. doi: 10.3978/j.issn.2225-319X.2015.05.01. No abstract available. PubMed 26309835 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03506217
Lead sponsor
Sakarya University
Responsible party
Havva Sayhan (Assistant Professor, Sakarya University) — Principal investigator
First posted
Apr 24, 2018
Start date
May 1, 2018 (estimated)
Primary completion
Aug 1, 2018 (estimated)
Completion
Jan 1, 2019 (estimated)
Last update
Apr 24, 2018

Study contacts

Havva Sayhan, Assis Prof
Contact
hsayhan@gmail.com
+905056621021
Umit Karadeniz, prof
Contact
ukaradeniz2003@gmail.com
+905326025264
Umit Karadeniz
study chair · Sakarya University Research and Training Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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