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

NCT ID: NCT03506217

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-01-01

Brief Summary

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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

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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.

Conditions

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Mitral Valve Prolapse

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Vigileo Flo-trac device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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Havva Sayhan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Umit Karadeniz

Role: STUDY_CHAIR

Sakarya University Research and Training Hospital

Locations

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Sakarya University Research and Training Hospital

Sakarya, Merkez, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Havva Sayhan, Assis Prof

Role: CONTACT

+905056621021

Umit Karadeniz, prof

Role: CONTACT

+905326025264

Facility Contacts

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Havva Sayhan, Assis Prof

Role: primary

+905056621021

umit Karadeniz

Role: backup

+905326025264

References

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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.

Reference Type RESULT
PMID: 26309835 (View on PubMed)

Other Identifiers

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neocorda

Identifier Type: -

Identifier Source: org_study_id

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