Mitral Valve ReconstructionNCT03818113
Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy
An observational study of Mitral Valve Reconstruction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution). This study investigates HTK-Bretschneider versus St. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Reconstruction
- What is being tested?
- cardioplegia with HTK-Bretschneider cardioplegic solution and cardioplegia with St. Thomas cardioplegic solution
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2019to 30 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with mitral valve reconstruction done via minimal invasive antero- lateral thoracotomy (2009-2018) at Universitätsspital Basel.
Who may be able to join
- Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
Who cannot join
- Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Herzchirurgie, Universitätsspital Basel
Basel, 4031
About this study
Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.
- Conditions
- Mitral Valve Reconstruction
- Being tested
- cardioplegia with HTK-Bretschneider cardioplegic solution, cardioplegia with St. Thomas cardioplegic solution
- Keywords
- mitral valve insufficiency, cardioplegia, cardioplegia Solution, HTK-Bretschneider (Custidiol®) solution, St. Thomas solution, cardiac biomarker
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardioplegia with HTK-Bretschneider cardioplegic solutionOther
cardioplegia with HTK-Bretschneider cardioplegic solution
cardioplegia with St. Thomas cardioplegic solutionOther
cardioplegia with St. Thomas cardioplegic solution
| Study group | Role | What they receive |
|---|---|---|
| HTK-Bretschneider cardioplegic solution | Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution Receives: Other: cardioplegia with HTK-Bretschneider cardioplegic solution | |
| St. Thomas cardioplegic solution | Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution Receives: Other: cardioplegia with St. Thomas cardioplegic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
high specific troponin T (hs-TrT) (μg/l)
cardial biomarker for myocardial damage
Measured: perioperative during minimal invasive surgery
Creatin-Phosphokinase (CK) (U/l)
cardial biomarker for myocardial damage
Measured: perioperative during minimal invasive surgery
Creatinkinase Muscle- Brain (CK-MB) (U/l)
cardial biomarker for myocardial damage
Measured: perioperative during minimal invasive surgery
Secondary outcomes (2)
mortality rate
number of deaths
Measured: from minimal invasive surgery until 30 days post surgery
length of stay in intensive care unit (days)
length of stay in intensive care unit (number of days)
Measured: from minimal invasive surgery until 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Apr 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ReconstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Grapow, Prof. Dr., Principal investigator, Klinik für Herzchirurgie, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818113
- Sponsor's protocol ID
- 2019-00070; ch18Grapow4
- Other IDs
- 2019
- Status last verified
- Nov 2019
- First submitted
- 23 Jan 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy
- ClinicalTrials.gov ID
- NCT03818113
- Acronym / sponsor ID
- 2019-00070; ch18Grapow4
- Conditions
- Mitral Valve Reconstruction
- Keywords
- mitral valve insufficiency, cardioplegia, cardioplegia Solution, HTK-Bretschneider (Custidiol®) solution, St. Thomas solution, cardiac biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 28 Jan 2019 (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.
Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTK-Bretschneider cardioplegic solution | – | Other: cardioplegia with HTK-Bretschneider cardioplegic solutionPatients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution |
| St. Thomas cardioplegic solution | – | Other: cardioplegia with St. Thomas cardioplegic solutionPatients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with mitral valve reconstruction done via minimal invasive antero- lateral thoracotomy (2009-2018) at Universitätsspital Basel.
Key inclusion criteria (1 listed)
- Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
Key exclusion criteria (1 listed)
- Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
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 |
|---|---|---|
| cardioplegia with HTK-Bretschneider cardioplegic solutioncardioplegia with HTK-Bretschneider cardioplegic solution | Other | HTK-Bretschneider cardioplegic solution |
| cardioplegia with St. Thomas cardioplegic solutioncardioplegia with St. Thomas cardioplegic solution | Other | St. Thomas cardioplegic solution |
Primary outcome
high specific troponin T (hs-TrT) (μg/l)
Time frame: perioperative during minimal invasive surgery
cardial biomarker for myocardial damage
Creatin-Phosphokinase (CK) (U/l)
Time frame: perioperative during minimal invasive surgery
cardial biomarker for myocardial damage
Creatinkinase Muscle- Brain (CK-MB) (U/l)
Time frame: perioperative during minimal invasive surgery
cardial biomarker for myocardial damage
2 secondary outcomes
mortality rate
Time frame: from minimal invasive surgery until 30 days post surgery
length of stay in intensive care unit (days)
Time frame: from minimal invasive surgery until 30 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
Related trials for Mitral Valve Reconstruction
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
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.
Martin Grapow, Prof. Dr. principal investigator
Klinik für Herzchirurgie, Universitätsspital Basel
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 Reconstruction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 6 Nov 2019. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high specific troponin T (hs-TrT) (μg/l) (time frame: perioperative during minimal invasive surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2019.