Cardiac Double Valve ReplacementNCT03667274
Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland
An observational study of Cardiac Double Valve Replacement, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
To compare patient outcome data after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Double Valve Replacement
- What is being tested?
- cardiac valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2018to 31 Aug 2020
- 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 undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009
Who may be able to join
- patients undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009
Who cannot join
- denial of consent
Trial locations and contacts
1 site in 1 country.
About this study
To compare patient outcome data after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction
Read the detailed description
To compare patient outcome data ( death, re-surgery, change in transvalvular gradient) after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction in patients with cardiac surgery at University Hospital Basel/ Switzerland since 2009.
- Conditions
- Cardiac Double Valve Replacement
- Being tested
- cardiac valve surgery
- Keywords
- aortic valve replacement, mitral valve reconstruction, mitral valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac valve surgeryProcedure or surgery
cardiac double valve surgery (aortic and mitral valve)
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death after cardiac valve surgery
Measured: time from hospitalisation for cardiac valve surgery and following 12 months
re-surgery
re-surgery after cardiac valve surgery
Measured: time from hospitalisation for cardiac valve surgery and following 12 months
change in transvalvular gradient
change in transvalvular Gradient after cardiac valve surgery
Measured: time from hospitalisation for cardiac valve surgery and following 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Apr 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
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 Cardiac Double Valve ReplacementStudies 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
- 106 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. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667274
- Sponsor's protocol ID
- 2018-00553; ch18Grapow2
- Other IDs
- 2018
- Status last verified
- Jun 2021
- First submitted
- 10 Sep 2018
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Egger ML, Gahl B, Koechlin L, Schomig L, Matt P, Reuthebuch O, Eckstein FS, Grapow MTR. Outcome of patients with double valve surgery between 2009 and 2018 at University Hospital Basel, Switzerland. J Cardiothorac Surg. 2022 Jun 13;17(1):152. doi: 10.1186/s13019-022-01904-9.
PubMed 35698233
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland
- ClinicalTrials.gov ID
- NCT03667274
- Acronym / sponsor ID
- 2018-00553; ch18Grapow2
- Conditions
- Cardiac Double Valve Replacement
- Keywords
- aortic valve replacement, mitral valve reconstruction, mitral valve replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 12 Sep 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.
To compare patient outcome data after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction
Detailed description
To compare patient outcome data ( death, re-surgery, change in transvalvular gradient) after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction in patients with cardiac surgery at University Hospital Basel/ Switzerland since 2009.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009
Key inclusion criteria (1 listed)
- patients undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009
Key exclusion criteria (1 listed)
- denial of consent
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 |
|---|---|---|
| cardiac valve surgerycardiac double valve surgery (aortic and mitral valve) | Procedure or surgery | – |
Primary outcome
death
Time frame: time from hospitalisation for cardiac valve surgery and following 12 months
death after cardiac valve surgery
re-surgery
Time frame: time from hospitalisation for cardiac valve surgery and following 12 months
re-surgery after cardiac valve surgery
change in transvalvular gradient
Time frame: time from hospitalisation for cardiac valve surgery and following 12 months
change in transvalvular Gradient after cardiac valve 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 22 Jun 2021.
- Derived from this study: PubMed 35698233Egger ML, Gahl B, Koechlin L, Schomig L, Matt P, Reuthebuch O, Eckstein FS, Grapow MTR. Outcome of patients with double valve surgery between 2009 and 2018 at University Hospital Basel, Switzerland. J Cardiothorac Surg. 2022 Jun 13;17(1):152. doi: 10.1186/s13019-022-01904-9.
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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.
Martin Grapow, Prof. Dr. MD principal investigator
University Hospital, Basel, Switzerland
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 Cardiac Double Valve Replacement, 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 22 Jun 2021. 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?
death (time frame: time from hospitalisation for cardiac valve surgery and following 12 months). 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?
On the ClinicalTrials.gov record for NCT03667274, 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 22 Jun 2021.