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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03506217
Other study ID # neocorda
Secondary ID
Status Recruiting
Phase
First received April 13, 2018
Last updated April 21, 2018
Start date May 1, 2018
Est. completion date January 1, 2019

Study information

Verified date April 2018
Source Sakarya University
Contact Havva Sayhan, Assis Prof
Phone +905056621021
Email hsayhan@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 13
Est. completion date January 1, 2019
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Sakarya University Research and Training Hospital Sakarya Merkez

Sponsors (1)

Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary invasive arterial cardiac output (CO) measurement A Vigileo Flotrac pulse counter invasive arterial cardiac output meter was used for cardiac output measurement. 1 month
Primary 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 1mounth
Primary 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). 1 mounth
Primary 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. 1 mounth
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