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

Mitral Valve Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506217
• Other study ID #: neocorda
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Mitral Valve Prolapse
• Prolapse

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