Mitral RegurgitationMITRAGEN5NCT07543874
MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry
An observational study of Mitral Regurgitation, run by University Hospital of Cologne.
Trial summary
The MITRAGEN5 Registry is an international, multicenter, observational registry that collects data on patients with mitral regurgitation who are treated with the fifth-generation MitraClip (G5) device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- MitraClip G5
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2030
- How long will I take part?
- 30 Days
- 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 with mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair using the MitraClip fifth-generation (G5) system at participating centers.
Who may be able to join
- Age 18 years or older at the time of M-TEER
- Treatment using the MitraClip G5 system
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Victor Mauri, MD contact
About this study
Official title: MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry (MITRAGEN5 Registry)
The MITRAGEN5 Registry is an international, multicenter, observational registry that collects data on patients with mitral regurgitation who are treated with the fifth-generation MitraClip (G5) device. The MitraClip is a small device used to repair the mitral valve of the heart without open-heart surgery, a procedure called mitral valve transcatheter edge-to-edge repair (M-TEER). This registry aims to evaluate how safe and effective the MitraClip G5 is in everyday clinical practice across multiple hospitals worldwide. All procedures, tests, and follow-up visits are part of routine clinical care. No additional study-specific procedures are performed. Data are collected in anonymized form from participating centers.
Read the detailed description
The MitraClip system is used for mitral valve transcatheter edge-to-edge repair, aimed at treating mitral regurgitation. The fifth generation (G5) introduces iterative enhancements to the delivery platform, including a redesigned steerable guide catheter, updated stabilizer with a new guide attach feature, and refined attachment and securement mechanisms. All these features are aimed at facilitating device handling, positioning, and procedural efficiency. The MitraClip sizes and their fundamental design remain unchanged from the fourth generation. This investigator-initiated registry aims to collect comprehensive real-world data from international high-volume centers to characterize the safety and effectiveness of the MitraClip G5 in a broad patient population treated according to local clinical practice. Enrollment includes retrospective data from patients treated since the introduction of the MitraClip G5 at each center. Data collection includes baseline clinical and echocardiographic characteristics, procedural details, in-hospital outcomes, and follow-up information available from routine clinical care.
- Conditions
- Mitral Regurgitation
- Being tested
- MitraClip G5
- Keywords
- MitraClip, Mitral Valve Transcatheter Edge-to-Edge Repair, M-TEER, MitraClip G5
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip G5Device
Fifth-generation MitraClip system for mitral valve transcatheter edge-to-edge repair, used as part of routine clinical care. No study-specific interventions are performed.
| Study group | Role | What they receive |
|---|---|---|
| MitraClip G5 Cohort | All patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) using the MitraClip fifth-generation (G5) system at participating centers. Receives: Device: MitraClip G5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients with Residual Mitral Regurgitation ≤1+ at Discharge
Proportion of patients with residual mitral regurgitation grade 1+ or less at hospital discharge, as assessed by transthoracic echocardiography.
Measured: At hospital discharge (typically 1-5 days post-procedure)
Secondary outcomes (5)
Change in NYHA Functional Class from Baseline to 30 Days
Change in New York Heart Association (NYHA) functional class from baseline to 30-day follow-up.
Measured: Baseline and 30 days post-procedure (window)
Rate of Major Adverse Events at 30 Days
Composite rate of major adverse events at 30 days, including death, stroke, device embolization, cardiac surgery for device-related complications, and need for reintervention.
Measured: 30 days post-procedure (window)
Rate of All-Cause Mortality at 30 Days
Rate of death from any cause within 30 days of the index procedure.
Measured: 30 days post-procedure (window)
Rate of Heart Failure Hospitalization at 30 Days
Rate of hospitalization for heart failure within 30 days of the index procedure.
Measured: 30 days post-procedure (window)
Proportion of Patients with Residual MR ≤1+ at 30 Days
Proportion of patients maintaining residual mitral regurgitation grade 1+ or less at 30-day follow-up, as assessed by transthoracic echocardiography.
Measured: 30 days post-procedure (window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center, Cardiovascular Research Foundation, New York
- Responsible party
- Principal investigator, Philipp von Stein, University Hospital of Cologne
- Investigators
- Philipp von Stein, MD, Principal investigator, University Hospital of CologneVictor Mauri, MD, Principal investigator, University Hospital of ColognePier Pasquale Leone, MD, MSc, Principal investigator, Montefiore Medical CenterAzeem Latib, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543874
- Sponsor's protocol ID
- MITRAGEN5-2025
- Acronym
- MITRAGEN5
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data may be shared with collaborating investigators for pre-approved sub-studies on a case-by-case basis upon reasonable request to the principal investigators.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry (MITRAGEN5 Registry)
- ClinicalTrials.gov ID
- NCT07543874
- Acronym / sponsor ID
- MITRAGEN5 / MITRAGEN5-2025
- Conditions
- Mitral Regurgitation
- Keywords
- MitraClip, Mitral Valve Transcatheter Edge-to-Edge Repair, M-TEER, MitraClip G5
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- Montefiore Medical Center, Cardiovascular Research Foundation, New York
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Apr 2026 (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.
The MITRAGEN5 Registry is an international, multicenter, observational registry that collects data on patients with mitral regurgitation who are treated with the fifth-generation MitraClip (G5) device. The MitraClip is a small device used to repair the mitral valve of the heart without open-heart surgery, a procedure called mitral valve transcatheter edge-to-edge repair (M-TEER). This registry aims to evaluate how safe and effective the MitraClip G5 is in everyday clinical practice across multiple hospitals worldwide. All procedures, tests, and follow-up visits are part of routine clinical care. No additional study-specific procedures are performed. Data are collected in anonymized form from participating centers.
Detailed description
The MitraClip system is used for mitral valve transcatheter edge-to-edge repair, aimed at treating mitral regurgitation. The fifth generation (G5) introduces iterative enhancements to the delivery platform, including a redesigned steerable guide catheter, updated stabilizer with a new guide attach feature, and refined attachment and securement mechanisms. All these features are aimed at facilitating device handling, positioning, and procedural efficiency. The MitraClip sizes and their fundamental design remain unchanged from the fourth generation. This investigator-initiated registry aims to collect comprehensive real-world data from international high-volume centers to characterize the safety and effectiveness of the MitraClip G5 in a broad patient population treated according to local clinical practice. Enrollment includes retrospective data from patients treated since the introduction of the MitraClip G5 at each center. Data collection includes baseline clinical and echocardiographic characteristics, procedural details, in-hospital outcomes, and follow-up information available from routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitraClip G5 Cohort | – | Device: MitraClip G5All patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) using the MitraClip fifth-generation (G5) system at participating centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair using the MitraClip fifth-generation (G5) system at participating centers.
Key inclusion criteria (2 listed)
- Age 18 years or older at the time of M-TEER
- Treatment using the MitraClip G5 system
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MitraClip G5Fifth-generation MitraClip system for mitral valve transcatheter edge-to-edge repair, used as part of routine clinical care. No study-specific interventions are performed. | Device | MitraClip G5 Cohort |
Primary outcome
Proportion of Patients with Residual Mitral Regurgitation ≤1+ at Discharge
Time frame: At hospital discharge (typically 1-5 days post-procedure)
Proportion of patients with residual mitral regurgitation grade 1+ or less at hospital discharge, as assessed by transthoracic echocardiography.
5 secondary outcomes
Change in NYHA Functional Class from Baseline to 30 Days
Time frame: Baseline and 30 days post-procedure (window)
Rate of Major Adverse Events at 30 Days
Time frame: 30 days post-procedure (window)
Rate of All-Cause Mortality at 30 Days
Time frame: 30 days post-procedure (window)
Rate of Heart Failure Hospitalization at 30 Days
Time frame: 30 days post-procedure (window)
Proportion of Patients with Residual MR ≤1+ at 30 Days
Time frame: 30 days post-procedure (window)
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 1 May 2026.
- Individual participant dataSharing planned: No. Anonymized data may be shared with collaborating investigators for pre-approved sub-studies on a case-by-case basis upon reasonable request to the principal investigators.
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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.
Victor Mauri, MD contact
Philipp von Stein, MD principal investigator
University Hospital of Cologne
Victor Mauri, MD principal investigator
University Hospital of Cologne
Pier Pasquale Leone, MD, MSc principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by University Hospital of Cologne.
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 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: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Philipp von Stein, MD (646-321-8145, philipp.von-stein@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with Residual Mitral Regurgitation ≤1+ at Discharge (time frame: At hospital discharge (typically 1-5 days post-procedure)). 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 1 May 2026.