NCT03506217

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

April 13, 2018

Last Update Submit

April 21, 2018

Conditions

Mitral Valve Prolapse

Keywords

mitral valve prolaps,chorda tendinea,cardiac output

Outcome Measures

Primary Outcomes (4)

  • invasive arterial cardiac output (CO) measurement

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

    1 month

  • 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

  • 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

  • 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

Study Arms (1)

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

Vigileo Flo-trac deviceDEVICE

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.

mitral valve prolaps

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Research and Training Hospital

Sakarya, Merkez, 54100, Turkey (Türkiye)

RECRUITING

Related 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. doi: 10.3978/j.issn.2225-319X.2015.05.01. No abstract available.

    PMID: 26309835RESULT

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve ProlapseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Umit Karadeniz

    Sakarya University Research and Training Hospital

    STUDY CHAIR

Central Study Contacts

Havva Sayhan, Assis Prof

CONTACT

+905056621021hsayhan@gmail.com

Umit Karadeniz, prof

CONTACT

+905326025264ukaradeniz2003@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 24, 2018

Study Start

May 1, 2018

Primary Completion

August 1, 2018

Study Completion

January 1, 2019

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

TU(1)