Mitral RegurgitationNCT02033811
MitraClip® Registry
An observational study of Mitral Regurgitation, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients. The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Dec 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients undergoing percutaneous mitral valve repair (PMVR) with the MitraClip® system
Who may be able to join
- severe mitral regurgitation
- percutaneous mitral valve repair (PMVR) with the MitraClip® system
Who cannot join
- < 18 years
- Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malte Kelm, MD contact
Germany1 site, 1 recruiting
- Recruiting
Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine
Düsseldorf, 40225
Malte Kelm, MD
Malte Kelm, MD
About this study
Official title: MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System
Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.
The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.
- Conditions
- Mitral Regurgitation
- Keywords
- mitral regurgitation, MitraClip system, percutaneous mitral valve repair
- Medical subject headings
- Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiac adverse events
increase in the 30-day risk of adverse events among patients receiving PMVR
Measured: 30 days
Secondary outcomes (1)
Mortality
Proportion of patients who are alive at 1 year after receiving
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Malte Kelm, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular MedicineMalte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033811
- Sponsor's protocol ID
- MitraClip® Registry
- Status last verified
- Feb 2020
- First submitted
- 9 Jan 2014
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Herbrand T, Eschenhagen S, Zeus T, Kehmeier E, Hellhammer K, Veulemans V, Kelm M, Balzer J. Acute reverse annular remodeling during MitraClip(R) therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study. Eur J Med Res. 2017 Sep 20;22(1):33. doi: 10.1186/s40001-017-0273-x.
PubMed 28931437Rammos C, Zeus T, Balzer J, Veulemans V, Hellhammer K, Niebel S, Kelm M, Rassaf T. Left Atrial and Left Ventricular Function and Remodeling Following Percutaneous Mitral Valve Repair. J Heart Valve Dis. 2016 May;25(3):309-319.
PubMed 27989041Hellhammer K, Zeus T, Balzer J, van Hall S, Rammos C, Wagstaff R, Kelm M, Rassaf T. Safety and efficacy of percutaneous mitral valve repair using the MitraClip(R) system in patients with diabetes mellitus. PLoS One. 2014 Nov 6;9(11):e111178. doi: 10.1371/journal.pone.0111178. eCollection 2014.
PubMed 25375257
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System
- ClinicalTrials.gov ID
- NCT02033811
- Acronym / sponsor ID
- MitraClip® Registry
- Conditions
- Mitral Regurgitation
- Keywords
- mitral regurgitation, MitraClip system, percutaneous mitral valve repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Jan 2014 (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.
Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.
The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing percutaneous mitral valve repair (PMVR) with the MitraClip® system
Key inclusion criteria (2 listed)
- severe mitral regurgitation
- percutaneous mitral valve repair (PMVR) with the MitraClip® system
Key exclusion criteria (2 listed)
- < 18 years
- Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major cardiac adverse events
Time frame: 30 days
increase in the 30-day risk of adverse events among patients receiving PMVR
1 secondary outcome
Mortality
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 28931437Herbrand T, Eschenhagen S, Zeus T, Kehmeier E, Hellhammer K, Veulemans V, Kelm M, Balzer J. Acute reverse annular remodeling during MitraClip(R) therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study. Eur J Med Res. 2017 Sep 20;22(1):33. doi: 10.1186/s40001-017-0273-x.
- Derived from this study: PubMed 27989041Rammos C, Zeus T, Balzer J, Veulemans V, Hellhammer K, Niebel S, Kelm M, Rassaf T. Left Atrial and Left Ventricular Function and Remodeling Following Percutaneous Mitral Valve Repair. J Heart Valve Dis. 2016 May;25(3):309-319.
- Derived from this study: PubMed 25375257Hellhammer K, Zeus T, Balzer J, van Hall S, Rammos C, Wagstaff R, Kelm M, Rassaf T. Safety and efficacy of percutaneous mitral valve repair using the MitraClip(R) system in patients with diabetes mellitus. PLoS One. 2014 Nov 6;9(11):e111178. doi: 10.1371/journal.pone.0111178. eCollection 2014.
- Related InfoLink provided by the sponsor.
Related trials for Mitral Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
Edge-to-edge Mitral Valve Repair in ATTR-CM
Mitral Regurgitation, ATTR-Cardiomyopathy
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.
Malte Kelm, MD contact
Malte Kelm, MD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine
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 Regurgitation, run by Klinik für Kardiologie, Pneumologie und Angiologie 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malte Kelm, MD (0049 211 81 18800), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiac adverse events (time frame: 30 days). 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 NCT02033811, which also lists 3 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 7 Feb 2020.