Aortic StenosisMITAVINCT04009434
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
A study testing Mitral Valve Clipping and TAVI in people with Aortic Stenosis and Mitral Regurgitation, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Aortic Stenosis, Mitral Regurgitation
- What is being tested?
- Mitral Valve Clipping and TAVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,162 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2019to 1 Aug 2023
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)
- Moderate to severe mitral regurgitation
- Symptom status NYHA II-III
- Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion
- Age ≥ 18 and < 90 years
- Written informed consent
Who cannot join
- MR mechanism/anatomy precluding MitraClip therapy
- Groin blood vessels are not eligible for TAVI procedure
- Massive or torrential tricuspid regurgitation
- Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.
- Life expectancy < 1 year due to non-cardiac conditions
- LVEF ≤ 25%
Show all 24Show fewer
- Hypotension (systolic pressure < 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support
- Cardiomyopathy other than dilated cardiomyopathy
- Fixed pulmonary artery systolic pressure > 70 mm Hg
- Any prior mitral valve surgery or transcatheter mitral valve procedure
- Stroke or transient ischemic event within 6 months prior to randomization
- Severe symptomatic carotid stenosis
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 90 days prior to randomization
- Untreated clinically significant coronary artery disease requiring revascularization
- Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization.
- Need for any other cardiovascular surgery (other than MV or AV disease)
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Active endocarditis or active infections requiring current antibiotic treatment
- Any condition making it unlikely that the patient will be able to complete all protocol procedures
- Patient unable to provide written informed consent prior to study enrolment
- Pregnant or nursing women
- Women of child bearing potential
- Current participation in any other interventional clinical trial
- Patients under legal supervision or guardianship Patients placed in an institution by official or court order
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heart-Center Dresden
Dresden, Saxony, 01307
Stephan Haussig, MD, +493514501704
About this study
Official title: Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.
- Conditions
- Aortic Stenosis, Mitral Regurgitation
- Being tested
- Mitral Valve Clipping, TAVI
- Keywords
- Aortic Stenosis, Aortic Disease, Transcatheter Aortic Valve Implantation, Mitral Regurgitation, Mitral Valve Regurgitation, Mitral Disease, Mitral valve clipping, MitraClip, Heart Valve Diseases
- Medical subject headings
- Aortic Valve Stenosis, Mitral Valve Insufficiency, Aortic Diseases, Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral Valve ClippingDevice
Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.
TAVIDevice
Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.
| Study group | Role | What they receive |
|---|---|---|
| TAVI | Other | Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy Receives: Device: TAVI |
| TAVI/MitraClip | Experimental | Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy. Receives: Device: Mitral Valve Clipping; Device: TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause and heart failure hospitalization
Composite endpoint of time to heart failure hospitalization or death from any cause
Measured: 1 year
Secondary outcomes (5)
Death from any cause
Time from randomization to death from any cause
Measured: 1, 2, 3, 4 years
Need for mitral valve reintervention
Need for mitral valve reintervention
Measured: 1, 2, 3, 4 years
Mitral regurgitation severity
Mitral regurgitation severity at 12 months
Measured: 1 year
6 Minute Walk Test
Change in 6 Minute Walk Test at 12 months
Measured: 1 year
New York Heart Association Functional Class
Course of New York Heart Association (NYHA) Functional Class at 1, 3, 6 months and 1, 2, 3, 4 years
Measured: 1, 3, 6 months and 1, 2, 3, 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Dec 2019
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Zentrum für Klinische Studien Leipzig, University Medical Center Mainz
- Responsible party
- Sponsor
- Investigators
- Axel Linke, MD, Principal investigator, Technische Universitaet Dresden, HEART CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009434
- Sponsor's protocol ID
- MITAVI
- Acronym
- MITAVI
- Status last verified
- Feb 2020
- First submitted
- 3 Jul 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After publication of the primary objective, the data might be provided to interested scientists on request (e.g. for meta-analyses, health related registers or other scientific questions) in an anonymized way within five years, if the members of the MITAVI-trial group agree.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04009434
- Acronym / sponsor ID
- MITAVI / MITAVI
- Conditions
- Aortic Stenosis, Mitral Regurgitation
- Keywords
- Aortic Stenosis, Aortic Disease, Transcatheter Aortic Valve Implantation, Mitral Regurgitation, Mitral Valve Regurgitation, Mitral Disease, Mitral valve clipping, MitraClip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,162 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Zentrum für Klinische Studien Leipzig, University Medical Center Mainz
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 5 Jul 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.
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI | Other | Device: TAVITransfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy |
| TAVI/MitraClip | Experimental | Device: Mitral Valve Clipping, Device: TAVITransfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)
- Moderate to severe mitral regurgitation
- Symptom status NYHA II-III
- Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion
- Age ≥ 18 and < 90 years
Key exclusion criteria (24 listed)
- MR mechanism/anatomy precluding MitraClip therapy
- Groin blood vessels are not eligible for TAVI procedure
- Massive or torrential tricuspid regurgitation
- Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.
- Life expectancy < 1 year due to non-cardiac conditions
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 |
|---|---|---|
| Mitral Valve ClippingPatients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy. | Device | TAVI/MitraClip |
| TAVITransfemoral transcatheter aortic valve implantation plus optimal standard of care therapy. | Device | TAVI, TAVI/MitraClip |
Primary outcome
Death from any cause and heart failure hospitalization
Time frame: 1 year
Composite endpoint of time to heart failure hospitalization or death from any cause
5 secondary outcomes
Death from any cause
Time frame: 1, 2, 3, 4 years
Need for mitral valve reintervention
Time frame: 1, 2, 3, 4 years
Mitral regurgitation severity
Time frame: 1 year
6 Minute Walk Test
Time frame: 1 year
New York Heart Association Functional Class
Time frame: 1, 3, 6 months and 1, 2, 3, 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided. After publication of the primary objective, the data might be provided to interested scientists on request (e.g. for meta-analyses, health related registers or other scientific questions) in an anonymized way within five years, if the members of the MITAVI-trial group agree.
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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.
Axel Linke, MD principal investigator
Technische Universitaet Dresden, HEART CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral Valve Clipping and TAVI in people with Aortic Stenosis and Mitral Regurgitation, run by Technische Universität Dresden 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 6 inclusion and 24 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 5 Feb 2020. 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?
Contact Axel Linke, MD (+49 351 4501704, mitavi@mailbox.tu-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause and heart failure hospitalization (time frame: 1 year). 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 Feb 2020.