Mitral Valve ProlapseNCT03506217
Using Pulse Counter Vigileo-Flotrac System in Transapical Off-pump Minimally Invasive Mitral Valve Repair
An observational study of Mitral Valve Prolapse, run by Sakarya University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mitral Valve Prolapse
- What is being tested?
- Vigileo Flo-trac device
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria are active endocarditis, functional or ischemic mitral insufficiency (MI), excessive calcific valves, leaflet perforation, anemic dilatation and severe left ventricular dysfunction.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University Research and Training Hospital
Sakarya, Merkez, 54100
Havva Sayhan, Assis Prof, +905056621021, hsayhan@gmail.com
umit Karadeniz, +905326025264, ukaradeniz2003@gmail.com
About this study
Official title: Hemodynamic Monitorization Using Pulse Counter Vigileo-Flotrac Cardiac Output System in Transapical Off-pump Minimally Invasive Mitral Valve Repair
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.
- Conditions
- Mitral Valve Prolapse
- Being tested
- Vigileo Flo-trac device
- Keywords
- mitral valve prolaps,, chorda tendinea,, cardiac output
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vigileo Flo-trac device |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive arterial cardiac output (CO) measurement
A Vigileo Flotrac pulse counter invasive arterial cardiac output meter was used for cardiac output measurement.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 1 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Sayhan, Sakarya University
- Investigators
- Umit Karadeniz, Study chair, Sakarya University Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506217
- Sponsor's protocol ID
- neocorda
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Monitorization Using Pulse Counter Vigileo-Flotrac Cardiac Output System in Transapical Off-pump Minimally Invasive Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT03506217
- Acronym / sponsor ID
- neocorda
- Conditions
- Mitral Valve Prolapse
- Keywords
- mitral valve prolaps,, chorda tendinea,, cardiac output
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mitral valve prolaps | – | Device: Vigileo Flo-trac deviceHemodynamic 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria are active endocarditis, functional or ischemic mitral insufficiency (MI), excessive calcific valves, leaflet perforation, anemic dilatation and severe left ventricular dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vigileo Flo-trac deviceA 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. | Device | mitral valve prolaps |
Primary outcome
invasive arterial cardiac output (CO) measurement
Time frame: 1 month
A Vigileo Flotrac pulse counter invasive arterial cardiac output meter was used for cardiac output measurement.
systemic vascular resistance (SVR)
Time frame: 1mounth
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
stroke volume variance (SVV)
Time frame: 1 mounth
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).
blood pressure
Time frame: 1 mounth
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Results publication: PubMed 26309835Colli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umit Karadeniz study chair
Sakarya University Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Prolapse, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Havva Sayhan, Assis Prof (+905056621021, hsayhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive arterial cardiac output (CO) measurement (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.