Mitral Valve DiseaseALIVENCT05345730
The Role of Left Atrial Fibrosis in Mitral Valve Repair Surgery (ALIVE Trial)
An observational study of Mitral Valve Disease and Mitral Regurgitation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse events. Currently, mitral valve repair surgery is the ultimate treatment for severe primary mitral valve insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mitral Valve Disease, Mitral Regurgitation, Surgery
- What is being tested?
- 3 DImensional Late Enhanced Gadolinium cardiac MRI scan
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Feb 2022to 31 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mitral valve insufficiency eligible for elective mitral valve repair surgery.
Who may be able to join
- Patients that meet the criteria for elective mitral valve repair surgery according to the European clinical guidelines (class I recommendation);
- Symptomatic, chronic severe mitral valve insufficiency due to degenerative valve disease with a left ventricular ejection fraction >30%.
- Asymptomatic, chronic severe mitral valve insufficiency due to degenerative valve disease with a left ventricular ejection fraction <60% and/or a left ventricular end-systolic diameter >45 mm.
Who cannot join
- not able to provide written informed consent.
- under the age of 18.
- with a history of cardiac surgery
- with atrial fibrillation
- with any comorbidity besides mitral valve insufficiency.
- with claustrophobia or any other contra-indication for magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse events.
Currently, mitral valve repair surgery is the ultimate treatment for severe primary mitral valve insufficiency. The main indications and timing for surgery are severe mitral valve insufficiency with symptoms or left ventricular dysfunction. However, the role of atrial fibrosis in this process remains undetermined despite its well-recognized clinical implications.
Read more
Characterization of atrial fibrosis patterns in mitral valve insufficiency patients might be potentially valuable for the indication and timing of mitral valve repair surgery in order to improve clinical outcomes.
To date, however, mitral valve insufficiency patients suffering from left atrial remodeling have hardly been studied using these new imaging techniques. Therefore, the investigators intend to combine advanced cardiac MRI and post-processing techniques prior to and after mitral valve repair surgery to gain more insight in the clinical implications of atrial fibrosis in this patient population.
It is hypothesized that the atrial fibrosis surface area paradoxically will increase after mitral valve surgery because of global shrinkage of the left atrium caused by the reversed remodeling process. As a consequence, more frequently atrial fibrosis related events including (paroxysmal) atrial fibrillation, may be observed in these patients.
Objective: To assess the effects of (reduced) volume overload on the left atrial wall texture (presence, amount and location of atrial fibrosis) and associated geometry and function in patients with mitral valve insufficiency, prior to and after mitral valve repair surgery.
Study design: Single center pilot study.
Study population: The research population consists of mitral valve insufficiency patients scheduled for elective surgical mitral valve repair (N=20) according to the current European guideline criteria.
Read the detailed description
Patients with mitral valve insufficiency frequently suffer from left atrial remodeling, caused by volume overload and subsequent atrial dilatation. The associated myocardial stretch and increased wall tension, trigger a cascade of pathways leading to the occurrence of atrial fibrosis as part of the remodeling process. The clinical relevance of this atrial fibrosis, is that its presence is associated with an increased risk of atrial fibrillation, heart failure, pulmonary hypertension, a reduced quality of life and eventually a shorter life expectancy. In addition, in patients suffering from atrial fibrillation, the presence and amount of left atrial fibrosis was found to be a strong predictor for ablation efficacy and long-term outcome.
In daily clinical practice, mitral valve insufficiency is managed either by medical or surgical therapy. However, since medical therapy is often not sufficient for patients with severe primary mitral valve insufficiency, surgical intervention remains the ultimate treatment option for these patients. In general, valve repair is the preferred type of surgery, since it has better clinical results compared to valve replacement.
Currently, the indication and timing for valve surgery is mainly based on the severity of mitral valve insufficiency and the presence of symptoms and/or severity of left ventricular dysfunction. For clinical decision making and patient stratification for mitral valve surgery, the presence of atrial fibrosis is currently not taken in account, despite its well-recognized clinical implications.
Detection of atrial fibrosis patterns in patients with severe mitral valve insufficiency, however, may be potentially valuable for the indication and timing of mitral valve repair surgery to improve clinical outcomes. Improved insight into atrial fibrosis patterns and changes after mitral valve repair due to reverse remodeling, may help clinicians in their clinical decision making and timing for surgery.
Today, quantification of atrial fibrosis can be routinely performed using cardiac Magnetic Resonance Imaging (MRI) techniques and advanced post-processing tools, offering non-invasive tissue characterization in thin-walled structures.
To date, mitral valve insufficiency patients suffering from left atrial remodeling have hardly been studied using these new imaging techniques. Therefore, in this study, the investigators want to combine advanced cardiac MRI and post-processing techniques prior to and after mitral valve repair surgery to gain insight on the clinical role and predictive value of atrial fibrosis in this patient population.
In addition, the investigators aim to assess the effects of (reduced) volume overload on atrial wall texture, geometry and function.
It is hypothesized that the atrial fibrosis surface area paradoxically will increase after mitral valve surgery because of global shrinkage of the left atrium caused by the reversed remodeling process. As a consequence, more frequently atrial fibrosis related events including (paroxysmal) atrial fibrillation, may be observed in these patients.
With this insight, cardiac MRI can become clinical valuable for the indication and timing of surgical intervention in these patients. Surgical therapy might be renounced for example when a substantial increase of fibrosis surface is expected post-surgically causing a higher risk for atrial fibrillation, heart failure, pulmonary hypertension and a reduced quality of life. On the contrary, surgical therapy might be considered in an earlier stage of disease when the amount of fibrosis is still limited regarding its expected post-surgical development.
- Conditions
- Mitral Valve Disease, Mitral Regurgitation, Surgery, Cardiac Valve Disease, Mitral Valve Surgery, Mitral Valve Repair
- Being tested
- 3 DImensional Late Enhanced Gadolinium cardiac MRI scan
- Medical subject headings
- Mitral Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 DImensional Late Enhanced Gadolinium cardiac MRI scanDiagnostic test
A cardiac MRI scan is made using late gadolinium enhancement to detect atrial fibrosis in the left atrium.
| Study group | Role | What they receive |
|---|---|---|
| Mitral valve insufficiency patients undergoing mitral valve repair surgery | The research population consists of mitral valve insufficiency patients scheduled for elective surgical mitral valve repair (N=20) according to the current European guideline criteria. These patients will undergo a cardiac MRI scan 2 weeks prior to surgery and 3 months after surgery. Receives: Diagnostic Test: 3 DImensional Late Enhanced Gadolinium cardiac MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of mitral valve insufficiency prior to surgery (regurgitation volume on MRI)
Severity of mitral valve insufficiency prior to surgery (defined as regurgitation volume in ml calculated using difference between left ventricular stroke volume (LVSV) and forward flow)
Measured: 2 weeks before surgery
Severity of mitral valve insufficiency after surgery (regurgitation volume on MRI)
Severity of mitral valve insufficiency after surgery (defined as regurgitation volume in ml calculated using difference between left ventricular stroke volume (LVSV) and forward flow)
Measured: 3 months after surgery
Left atrial remodelling prior to surgery (left atrial volume on MRI)
Left atrial volume (ml) measured by multislice volumetric method on MRI
Measured: 2 weeks before surgery
Left atrial remodelling after surgery (left atrial volume on MRI)
Left atrial volume (ml) measured by multislice volumetric method on MRI
Measured: 3 months after surgery
Left atrial remodelling prior to surgery (left atrial sphericity on MRI)
Calculated left atrial sphericity by using ratio of transverse and longitudinal diameters of the left atrium
Measured: 2 weeks before surgery
Left atrial remodelling after surgery (left atrial sphericity on MRI)
Calculated left atrial sphericity by using ratio of transverse and longitudinal diameters of the left atrium
Measured: 3 months after surgery
Left atrial remodelling prior to surgery (estimated wall tension)
Estimated wall tension using a calculation combining left atrial wall thickness, left atrial radius and pulmonary wedge pressure. Wall thickness and radius will be measured on MRI. Pulmonary wedge pressure will be measured by using a Swan-Ganz catheter during surgery
Measured: 2 weeks before surgery
Left atrial remodelling after surgery (estimated wall tension)
Estimated wall tension using a calculation combining left atrial wall thickness, left atrial radius and pulmonary wedge pressure. Wall thickness and radius will be measured on MRI. Pulmonary wedge pressure will be measured by using a Swan-Ganz catheter during surgery
Measured: 3 months after surgery
Presence and distribution patterns of LA fibrosis prior to surgery (quantification of fibrosis surface)
Quantification of fibrosis surface will be assessed by using dedicated software Cricle ADAS which is able to segment the left atrial wall and recognize fibrotic tissue by means of late gadolinium enhancement
Measured: 2 weeks before surgery
Presence and distribution patterns of LA fibrosis after surgery (quantification of fibrosis surface)
Quantification of fibrosis surface will be assessed by using dedicated software Cricle ADAS which is able to segment the left atrial wall and recognize fibrotic tissue by means of late gadolinium enhancement
Measured: 3 months after surgery
Presence and distribution patterns of LA fibrosis prior to surgery (geometric distribution of fibrosis)
Geometric distribution of fibrosis in the left atrium will be assessed using dedicated software Circle ADAS. The software is able to segment the left atrial and define the three-dimensional geometric distribution of fibrotic tissue
Measured: 2 weeks before surgery
Presence and distribution patterns of LA fibrosis after surgery (geometric distribution of fibrosis)
Geometric distribution of fibrosis in the left atrium will be assessed using dedicated software Circle ADAS. The software is able to segment the left atrial and define the three-dimensional geometric distribution of fibrotic tissue
Measured: 3 months after surgery
Blood flow patterns in the left atrium prior to surgery (flow velocity)
Blood flow patterns in the left atrium will be assessed by measuring flow velocity using synthetic velocity fields as well as Poiseuille flow. This will be done with dedicated software Circle
Measured: 2 weeks before surgery
Blood flow patterns in the left atrium after surgery (flow velocity)
Blood flow patterns in the left atrium will be assessed by measuring flow velocity using synthetic velocity fields as well as Poiseuille flow. This will be done with dedicated software Circle
Measured: 3 months after surgery
Blood flow patterns in the left atrium prior to surgery (kinetic energy)
Kinetic energy of the blood flow patterns will be measured by using dedicated software Circle by means of advanced 4D flow CRM techniques defining global kinetic energy
Measured: 2 weeks before surgery
Blood flow patterns in the left atrium after surgery (kinetic energy)
Kinetic energy of the blood flow patterns will be measured by using dedicated software Circle by means of advanced 4D flow CRM techniques defining global kinetic energy
Measured: 3 months after surgery
Secondary outcomes (6)
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - NT-proBNP
NT-proBNP
Measured: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - TGF-β
TGF-β
Measured: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - TNF-alfa
TNF-alfa
Measured: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - Galectin-3
Galectin-3
Measured: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - MMS
MMS
Measured: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - Angiotensin II
Angiotensin II
Measured: 2 weeks before surgery and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start2 Feb 2022
- Primary completion1 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanda Kluin, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jolanda Kluin, M.D., PhD, Principal investigator, j.kluin@amsterdamumc.nl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345730
- Sponsor's protocol ID
- NL78497.018.21
- Acronym
- ALIVE
- Status last verified
- Jul 2024
- First submitted
- 12 Jan 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When asked for, a construction will be made to share data. At the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Left Atrial Fibrosis in Mitral Valve Repair Surgery (ALIVE Trial)
- ClinicalTrials.gov ID
- NCT05345730
- Acronym / sponsor ID
- ALIVE / NL78497.018.21
- Conditions
- Mitral Valve Disease, Mitral Regurgitation, Surgery, Cardiac Valve Disease, Mitral Valve Surgery, Mitral Valve Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Apr 2022 (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.
Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse events.
Currently, mitral valve repair surgery is the ultimate treatment for severe primary mitral valve insufficiency. The main indications and timing for surgery are severe mitral valve insufficiency with symptoms or left ventricular dysfunction. However, the role of atrial fibrosis in this process remains undetermined despite its well-recognized clinical implications.
Characterization of atrial fibrosis patterns in mitral valve insufficiency patients might be potentially valuable for the indication and timing of mitral valve repair surgery in order to improve clinical outcomes.
To date, however, mitral valve insufficiency patients suffering from left atrial remodeling have hardly been studied using these new imaging techniques. Therefore, the investigators intend to combine advanced cardiac MRI and post-processing techniques prior to and after mitral valve repair surgery to gain more insight in the clinical implications of atrial fibrosis in this patient population.
It is hypothesized that the atrial fibrosis surface area paradoxically will increase after mitral valve surgery because of global shrinkage of the left atrium caused by the reversed remodeling process. As a consequence, more frequently atrial fibrosis related events including (paroxysmal) atrial fibrillation, may be observed in these patients.
Objective: To assess the effects of (reduced) volume overload on the left atrial wall texture (presence, amount and location of atrial fibrosis) and associated geometry and function in patients with mitral valve insufficiency, prior to and after mitral valve repair surgery.
Study design: Single center pilot study.
Study population: The research population consists of mitral valve insufficiency patients scheduled for elective surgical mitral valve repair (N=20) according to the current European guideline criteria.
Detailed description
Patients with mitral valve insufficiency frequently suffer from left atrial remodeling, caused by volume overload and subsequent atrial dilatation. The associated myocardial stretch and increased wall tension, trigger a cascade of pathways leading to the occurrence of atrial fibrosis as part of the remodeling process. The clinical relevance of this atrial fibrosis, is that its presence is associated with an increased risk of atrial fibrillation, heart failure, pulmonary hypertension, a reduced quality of life and eventually a shorter life expectancy. In addition, in patients suffering from atrial fibrillation, the presence and amount of left atrial fibrosis was found to be a strong predictor for ablation efficacy and long-term outcome.
In daily clinical practice, mitral valve insufficiency is managed either by medical or surgical therapy. However, since medical therapy is often not sufficient for patients with severe primary mitral valve insufficiency, surgical intervention remains the ultimate treatment option for these patients. In general, valve repair is the preferred type of surgery, since it has better clinical results compared to valve replacement.
Currently, the indication and timing for valve surgery is mainly based on the severity of mitral valve insufficiency and the presence of symptoms and/or severity of left ventricular dysfunction. For clinical decision making and patient stratification for mitral valve surgery, the presence of atrial fibrosis is currently not taken in account, despite its well-recognized clinical implications.
Detection of atrial fibrosis patterns in patients with severe mitral valve insufficiency, however, may be potentially valuable for the indication and timing of mitral valve repair surgery to improve clinical outcomes. Improved insight into atrial fibrosis patterns and changes after mitral valve repair due to reverse remodeling, may help clinicians in their clinical decision making and timing for surgery.
Today, quantification of atrial fibrosis can be routinely performed using cardiac Magnetic Resonance Imaging (MRI) techniques and advanced post-processing tools, offering non-invasive tissue characterization in thin-walled structures.
To date, mitral valve insufficiency patients suffering from left atrial remodeling have hardly been studied using these new imaging techniques. Therefore, in this study, the investigators want to combine advanced cardiac MRI and post-processing techniques prior to and after mitral valve repair surgery to gain insight on the clinical role and predictive value of atrial fibrosis in this patient population.
In addition, the investigators aim to assess the effects of (reduced) volume overload on atrial wall texture, geometry and function.
It is hypothesized that the atrial fibrosis surface area paradoxically will increase after mitral valve surgery because of global shrinkage of the left atrium caused by the reversed remodeling process. As a consequence, more frequently atrial fibrosis related events including (paroxysmal) atrial fibrillation, may be observed in these patients.
With this insight, cardiac MRI can become clinical valuable for the indication and timing of surgical intervention in these patients. Surgical therapy might be renounced for example when a substantial increase of fibrosis surface is expected post-surgically causing a higher risk for atrial fibrillation, heart failure, pulmonary hypertension and a reduced quality of life. On the contrary, surgical therapy might be considered in an earlier stage of disease when the amount of fibrosis is still limited regarding its expected post-surgical development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral valve insufficiency patients undergoing mitral valve repair surgery | – | Diagnostic Test: 3 DImensional Late Enhanced Gadolinium cardiac MRI scanThe research population consists of mitral valve insufficiency patients scheduled for elective surgical mitral valve repair (N=20) according to the current European guideline criteria. These patients will undergo a cardiac MRI scan 2 weeks prior to surgery and 3 months after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mitral valve insufficiency eligible for elective mitral valve repair surgery.
Key inclusion criteria (3 listed)
- Patients that meet the criteria for elective mitral valve repair surgery according to the European clinical guidelines (class I recommendation);
Key exclusion criteria (6 listed)
- not able to provide written informed consent.
- under the age of 18.
- with a history of cardiac surgery
- with atrial fibrillation
- with any comorbidity besides mitral valve insufficiency.
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 |
|---|---|---|
| 3 DImensional Late Enhanced Gadolinium cardiac MRI scanA cardiac MRI scan is made using late gadolinium enhancement to detect atrial fibrosis in the left atrium. | Diagnostic test | Mitral valve insufficiency patients undergoing mitral valve repair surgery |
Primary outcome
Severity of mitral valve insufficiency prior to surgery (regurgitation volume on MRI)
Time frame: 2 weeks before surgery
Severity of mitral valve insufficiency prior to surgery (defined as regurgitation volume in ml calculated using difference between left ventricular stroke volume (LVSV) and forward flow)
Severity of mitral valve insufficiency after surgery (regurgitation volume on MRI)
Time frame: 3 months after surgery
Severity of mitral valve insufficiency after surgery (defined as regurgitation volume in ml calculated using difference between left ventricular stroke volume (LVSV) and forward flow)
Left atrial remodelling prior to surgery (left atrial volume on MRI)
Time frame: 2 weeks before surgery
Left atrial volume (ml) measured by multislice volumetric method on MRI
Left atrial remodelling after surgery (left atrial volume on MRI)
Time frame: 3 months after surgery
Left atrial volume (ml) measured by multislice volumetric method on MRI
Left atrial remodelling prior to surgery (left atrial sphericity on MRI)
Time frame: 2 weeks before surgery
Calculated left atrial sphericity by using ratio of transverse and longitudinal diameters of the left atrium
Left atrial remodelling after surgery (left atrial sphericity on MRI)
Time frame: 3 months after surgery
Calculated left atrial sphericity by using ratio of transverse and longitudinal diameters of the left atrium
Left atrial remodelling prior to surgery (estimated wall tension)
Time frame: 2 weeks before surgery
Estimated wall tension using a calculation combining left atrial wall thickness, left atrial radius and pulmonary wedge pressure. Wall thickness and radius will be measured on MRI. Pulmonary wedge pressure will be measured by using a Swan-Ganz catheter during surgery
Left atrial remodelling after surgery (estimated wall tension)
Time frame: 3 months after surgery
Estimated wall tension using a calculation combining left atrial wall thickness, left atrial radius and pulmonary wedge pressure. Wall thickness and radius will be measured on MRI. Pulmonary wedge pressure will be measured by using a Swan-Ganz catheter during surgery
Presence and distribution patterns of LA fibrosis prior to surgery (quantification of fibrosis surface)
Time frame: 2 weeks before surgery
Quantification of fibrosis surface will be assessed by using dedicated software Cricle ADAS which is able to segment the left atrial wall and recognize fibrotic tissue by means of late gadolinium enhancement
Presence and distribution patterns of LA fibrosis after surgery (quantification of fibrosis surface)
Time frame: 3 months after surgery
Quantification of fibrosis surface will be assessed by using dedicated software Cricle ADAS which is able to segment the left atrial wall and recognize fibrotic tissue by means of late gadolinium enhancement
Presence and distribution patterns of LA fibrosis prior to surgery (geometric distribution of fibrosis)
Time frame: 2 weeks before surgery
Geometric distribution of fibrosis in the left atrium will be assessed using dedicated software Circle ADAS. The software is able to segment the left atrial and define the three-dimensional geometric distribution of fibrotic tissue
Presence and distribution patterns of LA fibrosis after surgery (geometric distribution of fibrosis)
Time frame: 3 months after surgery
Geometric distribution of fibrosis in the left atrium will be assessed using dedicated software Circle ADAS. The software is able to segment the left atrial and define the three-dimensional geometric distribution of fibrotic tissue
Blood flow patterns in the left atrium prior to surgery (flow velocity)
Time frame: 2 weeks before surgery
Blood flow patterns in the left atrium will be assessed by measuring flow velocity using synthetic velocity fields as well as Poiseuille flow. This will be done with dedicated software Circle
Blood flow patterns in the left atrium after surgery (flow velocity)
Time frame: 3 months after surgery
Blood flow patterns in the left atrium will be assessed by measuring flow velocity using synthetic velocity fields as well as Poiseuille flow. This will be done with dedicated software Circle
Blood flow patterns in the left atrium prior to surgery (kinetic energy)
Time frame: 2 weeks before surgery
Kinetic energy of the blood flow patterns will be measured by using dedicated software Circle by means of advanced 4D flow CRM techniques defining global kinetic energy
Blood flow patterns in the left atrium after surgery (kinetic energy)
Time frame: 3 months after surgery
Kinetic energy of the blood flow patterns will be measured by using dedicated software Circle by means of advanced 4D flow CRM techniques defining global kinetic energy
6 secondary outcomes
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - NT-proBNP
Time frame: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - TGF-β
Time frame: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - TNF-alfa
Time frame: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - Galectin-3
Time frame: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - MMS
Time frame: 2 weeks before surgery and 3 months after surgery
Change of fibrosis associated biomarkers derived from blood samples (prior to surgery versus after surgery) - Angiotensin II
Time frame: 2 weeks before surgery and 3 months after 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 5 Jul 2024.
- Individual participant dataSharing planned: Undecided. When asked for, a construction will be made to share data. At the end of the study.
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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.
Jolanda Kluin, M.D., PhD principal investigator
j.kluin@amsterdamumc.nl
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 Disease and Mitral Regurgitation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 inclusion and 6 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 5 Jul 2024. 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 Netherlands. 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?
Severity of mitral valve insufficiency prior to surgery (regurgitation volume on MRI) (time frame: 2 weeks before surgery). The study lists 16 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 5 Jul 2024.