Mitral Valve InsufficiencyNCT03024268
MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure
A study testing Figulla Flex Occluder (Occlutech) in people with Mitral Valve Insufficiency and Heart Septal Defects, Atrial, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial summary
Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Heart Septal Defects, Atrial
- What is being tested?
- Figulla Flex Occluder (Occlutech)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Dec 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Previous MitraClip implantation
- Persistent relevant iASD 30 days after MitraClip intervention
Who cannot join
- Unsuccessful MitraClip implantation
- No relevant iASD 30 days after MitraClip intervention
- Unstable angina in the previous 4 weeks
- Valvular heart disease (aortic, tricuspid or pulmonary valve) planed for surgery or interventional therapy
- Constrictive pericarditis / restrictive cardiomyopathies
- Pericardial effusion planed for surgery or interventional therapy
Show all 15Show fewer
- Coagulation disorders
- Malignant disease with a life expectance < 12 months
- Pregnancy
- Participation in another study
- iASD diameter > 38 mm
- Aortic minimum distance of the iASD < 5 mm
- Thrombus in left atrial appendage
- Venous access impossible with a 24 French catheter system
- Presence of an inferior vena cava filter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting
Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.
Read the detailed description
Transcatheter mitral valve repair with the MitraClip system is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. There is evidence that the persistence of a relevant iASD after MitraClip is associated with worse clinical outcomes and increased mortality.
The purpose of this study is to investigate, if the interventional closure of an persistant hemodynamic relevant iASD 30 days after MitraClip implantation, has favorable effects on clinical outcome. Eligible patients, after obtaining written informed consent, are 1:1 randomized either in group A (interventional occlusion of iASD) or group B (best supportive care).
- Being tested
- Figulla Flex Occluder (Occlutech)
- Medical subject headings
- Mitral Valve Insufficiency, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Figulla Flex Occluder (Occlutech)Device
Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)
| Study group | Role | What they receive |
|---|---|---|
| A: interventional closure of iASD | Experimental | Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech) Receives: Device: Figulla Flex Occluder (Occlutech) |
| B: no intervention | No intervention | Best medical supportive care (n=40) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise tolerance: 6 minute walking test
Measured: baseline, 3 and 6 months
Secondary outcomes (16)
Change in New York Heart Association Functional Classification assessment
Changes in New York Heart Association Functional Classification
Measured: baseline, 3 and 6 months
Changes in Echocardiography: bi ventricular function (2D and 3D)
Measured: baseline, 3 and 6 months
Changes in Echocardiography: assessment of left atrium (2D and 3D)
Measured: baseline, 3 and 6 months
Changes in Echocardiography: assessment of heart valves
Measured: baseline, 3 and 6 months
Changes in Echocardiography: strain using speckle tracking
Measured: baseline, 3 and 6 months
Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)
Measured: baseline, 3 and 6 months
Heart insufficiency bio markers
Measured: baseline and 6 months
Changes in Cardiac MRI: bi ventricular function
Measured: baseline and 6 months
Changes in Cardiac MRI: left ventricular longitudinal strain
Measured: baseline and 6 months
Changes in Cardiac MRI: left ventricular circumferential strain
Measured: baseline and 6 months
Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta
Measured: baseline and 6 months
Evaluation of hospitalisation rate
Telephone
Measured: baseline, 3, 6 and 12 months
Evaluation of mortality
Telephone
Measured: baseline, 3, 6 and 12 months
Combined endpoint (hospitalisation and mortality)
Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.
Measured: baseline, 3, 6 and 12 months
Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire
Measured: baseline and 6 months
Changes in quality of life in "Short Form - 36" questionnaire
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionSep 2020
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lurz, Heart Center Leipzig - University Hospital
- Investigators
- Philipp Lurz, MD, PhD, Principal investigator, Heart Center of the University LeipzigStephan Blazek, MD, Study chair, Heart Center of the University Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024268
- Sponsor's protocol ID
- MITHRAS
- Status last verified
- May 2021
- First submitted
- 29 Dec 2016
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Blazek S, Unterhuber M, Rommel KP, Kresoja KP, Kister T, Besler C, Fengler K, Rosch S, Daehnert I, Thiele H, Lurz P, von Roeder M. Fate of iatrogenic atrial septal defects following mitral transcatheter edge-to-edge repair - a subanalysis of the MITHRAS trial. Int J Cardiovasc Imaging. 2023 Mar;39(3):519-530. doi: 10.1007/s10554-022-02750-5. Epub 2022 Nov 13.
PubMed 36371488Lurz P, Unterhuber M, Rommel KP, Kresoja KP, Kister T, Besler C, Fengler K, Sandri M, Daehnert I, Thiele H, Blazek S, von Roeder M. Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Repair and Implications of Interventional Closure. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2685-2694. doi: 10.1016/j.jcin.2021.09.023.
PubMed 34949392
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting
- ClinicalTrials.gov ID
- NCT03024268
- Acronym / sponsor ID
- MITHRAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- 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.
Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.
Detailed description
Transcatheter mitral valve repair with the MitraClip system is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. There is evidence that the persistence of a relevant iASD after MitraClip is associated with worse clinical outcomes and increased mortality.
The purpose of this study is to investigate, if the interventional closure of an persistant hemodynamic relevant iASD 30 days after MitraClip implantation, has favorable effects on clinical outcome. Eligible patients, after obtaining written informed consent, are 1:1 randomized either in group A (interventional occlusion of iASD) or group B (best supportive care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: interventional closure of iASD | Experimental | Device: Figulla Flex Occluder (Occlutech)Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech) |
| B: no intervention | No intervention | –Best medical supportive care (n=40) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Previous MitraClip implantation
- Persistent relevant iASD 30 days after MitraClip intervention
Key exclusion criteria (15 listed)
- Unsuccessful MitraClip implantation
- No relevant iASD 30 days after MitraClip intervention
- Unstable angina in the previous 4 weeks
- Valvular heart disease (aortic, tricuspid or pulmonary valve) planed for surgery or interventional therapy
- Constrictive pericarditis / restrictive cardiomyopathies
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 |
|---|---|---|
| Figulla Flex Occluder (Occlutech)Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech) | Device | A: interventional closure of iASD |
Primary outcome
Change in Exercise tolerance: 6 minute walking test
Time frame: baseline, 3 and 6 months
16 secondary outcomes
Change in New York Heart Association Functional Classification assessment
Time frame: baseline, 3 and 6 months
Changes in Echocardiography: bi ventricular function (2D and 3D)
Time frame: baseline, 3 and 6 months
Changes in Echocardiography: assessment of left atrium (2D and 3D)
Time frame: baseline, 3 and 6 months
Changes in Echocardiography: assessment of heart valves
Time frame: baseline, 3 and 6 months
Changes in Echocardiography: strain using speckle tracking
Time frame: baseline, 3 and 6 months
Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)
Time frame: baseline, 3 and 6 months
Heart insufficiency bio markers
Time frame: baseline and 6 months
Changes in Cardiac MRI: bi ventricular function
Time frame: baseline and 6 months
Changes in Cardiac MRI: left ventricular longitudinal strain
Time frame: baseline and 6 months
Changes in Cardiac MRI: left ventricular circumferential strain
Time frame: baseline and 6 months
Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta
Time frame: baseline and 6 months
Evaluation of hospitalisation rate
Time frame: baseline, 3, 6 and 12 months
Evaluation of mortality
Time frame: baseline, 3, 6 and 12 months
Combined endpoint (hospitalisation and mortality)
Time frame: baseline, 3, 6 and 12 months
Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire
Time frame: baseline and 6 months
Changes in quality of life in "Short Form - 36" questionnaire
Time frame: baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 36371488Blazek S, Unterhuber M, Rommel KP, Kresoja KP, Kister T, Besler C, Fengler K, Rosch S, Daehnert I, Thiele H, Lurz P, von Roeder M. Fate of iatrogenic atrial septal defects following mitral transcatheter edge-to-edge repair - a subanalysis of the MITHRAS trial. Int J Cardiovasc Imaging. 2023 Mar;39(3):519-530. doi: 10.1007/s10554-022-02750-5. Epub 2022 Nov 13.
- Derived from this study: PubMed 34949392Lurz P, Unterhuber M, Rommel KP, Kresoja KP, Kister T, Besler C, Fengler K, Sandri M, Daehnert I, Thiele H, Blazek S, von Roeder M. Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Repair and Implications of Interventional Closure. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2685-2694. doi: 10.1016/j.jcin.2021.09.023.
- 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.
Philipp Lurz, MD, PhD principal investigator
Heart Center of the University Leipzig
Stephan Blazek, MD study chair
Heart Center of the University Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Figulla Flex Occluder (Occlutech) in people with Mitral Valve Insufficiency and Heart Septal Defects, Atrial, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
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 15 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 10 May 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 Germany. 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?
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?
Change in Exercise tolerance: 6 minute walking test (time frame: baseline, 3 and 6 months). 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 NCT03024268, which also lists 2 linked publications.
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 10 May 2021.