Mitral RegurgitationNCT06814210
CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
A study testing Cerebral Embolic Protection in people with Mitral Regurgitation and Functional Mitral Regurgitation, run by Xiao-dong Zhuang at 1 site in China.
Trial summary
Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation
- What is being tested?
- Cerebral Embolic Protection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Oct 2025
- Phase
- Interventional
- 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
Who may be able to join
- Subjects must meet ALL of the following criteria:
- General Inclusion Criteria
- Age ≥18 years
- Severe Mitral Regurgitation (3+ to 4+)
- Symptom status: NYHA functional class ≥ II
- Subjects scheduled to receive the M-TEER per the current approved indications for use
- Subjects agreed to join the study and complete follow-up
Who cannot join
- Potential Subjects will be excluded if ANY of the following criteria apply:
- General Exclusion Criteria
- Contraindication to MRI
- CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days
- Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
- COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
Show all 16Show fewer
- Cerebrovascular accident within prior 30 days
- Severe symptomatic carotid stenosis (>70% by ultrasound)
- Carotid surgery or stenting within prior 30 days
- Hemodynamic instability requiring inotropic support or mechanical heart assistance
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
- Contraindication for transesophageal echocardiography
- Life expectancy < 1 year
- Pregnant or planning pregnancy within next 12 months
- Participation in another interventional Trial
- Patients who are not able to give consent or complete the follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Xiao-dong Zhuang MD, +8613760755035, zhuangxd3@mail.sysu.edu.cn
About this study
Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices.
This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.
Read the detailed description
Subjects with indications for M-TEER and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms: 1) intervention: cerebral protection device with M-TEER or 2) Control: Unprotected M-TEER.
Enrolled subjects will undergo a diffusion weighted magnetic resonance imaging (DW-MRI) at baseline and at 72 hours, to evaluate any new cerebral lesions. Enrolled subjects will be followed for 30 days.
The study aims to address:
- To determine whether the total amounts of new brain lesion assessed by diffusion weighted magnetic resonance images at 72 hours is comparable between the experimental group and the control group.
- To assess the effectiveness and safety of cerebral protection device in the prevention of perioperative cerebrovascular events after M-TEER
- To explore the correlation between the volume/number/location of new brain lesions and changes in neurocognitive function
- To evaluate the histopathological features of the captured fragments and their relevance to clinical features
- Conditions
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation
- Being tested
- Cerebral Embolic Protection
- 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.
Cerebral Embolic ProtectionDevice
Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Embolic Protection | Experimental | Subjects will undergo M-TEER following placement of the cerebral embolic protection device. Receives: Device: Cerebral Embolic Protection |
| Control Arm | No intervention | Subjects will undergo M-TEER without cerebral embolic protection device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amounts of new lesions
Total amounts of new lesions in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours.
Measured: 72 hours
Secondary outcomes (5)
Total new lesion volume
Total new lesion volume assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours
Measured: 72 hours
Incidence of delirium
Incidence of delirium
Measured: 7 days
NIHSS worsening
NIHSS worsening
Measured: 30 days
Incidence of peri- and postprocedural stroke
Incidence of peri- and postprocedural stroke
Measured: 30 days
Incidences of MACCE at 30 days
The incidences of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days defined as all-cause mortality, all stroke, life-threatening or disabling bleeding, major vascular complications, and acute kidney injury (stage 2 or 3, including renal replacement therapy)
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao-dong Zhuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao-dong Zhuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814210
- Sponsor's protocol ID
- CAP-TEER
- Status last verified
- Feb 2025
- First submitted
- 19 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
- ClinicalTrials.gov ID
- NCT06814210
- Acronym / sponsor ID
- CAP-TEER
- Conditions
- Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xiao-dong ZhuangUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 7 Feb 2025 (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.
Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices.
This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.
Detailed description
Subjects with indications for M-TEER and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms: 1) intervention: cerebral protection device with M-TEER or 2) Control: Unprotected M-TEER.
Enrolled subjects will undergo a diffusion weighted magnetic resonance imaging (DW-MRI) at baseline and at 72 hours, to evaluate any new cerebral lesions. Enrolled subjects will be followed for 30 days.
The study aims to address:
- To determine whether the total amounts of new brain lesion assessed by diffusion weighted magnetic resonance images at 72 hours is comparable between the experimental group and the control group.
- To assess the effectiveness and safety of cerebral protection device in the prevention of perioperative cerebrovascular events after M-TEER
- To explore the correlation between the volume/number/location of new brain lesions and changes in neurocognitive function
- To evaluate the histopathological features of the captured fragments and their relevance to clinical features
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Embolic Protection | Experimental | Device: Cerebral Embolic ProtectionSubjects will undergo M-TEER following placement of the cerebral embolic protection device. |
| Control Arm | No intervention | –Subjects will undergo M-TEER without cerebral embolic protection device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- General Inclusion Criteria
- Age ≥18 years
- Severe Mitral Regurgitation (3+ to 4+)
- Symptom status: NYHA functional class ≥ II
- Subjects scheduled to receive the M-TEER per the current approved indications for use
Key exclusion criteria (16 listed)
- General Exclusion Criteria
- Contraindication to MRI
- CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days
- Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
- COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
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 |
|---|---|---|
| Cerebral Embolic ProtectionSubjects will undergo M-TEER following placement of the cerebral embolic protection device. | Device | Cerebral Embolic Protection |
Primary outcome
Total amounts of new lesions
Time frame: 72 hours
Total amounts of new lesions in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours.
5 secondary outcomes
Total new lesion volume
Time frame: 72 hours
Incidence of delirium
Time frame: 7 days
NIHSS worsening
Time frame: 30 days
Incidence of peri- and postprocedural stroke
Time frame: 30 days
Incidences of MACCE at 30 days
Time frame: 30 days and 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 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral Embolic Protection in people with Mitral Regurgitation and Functional Mitral Regurgitation, run by Xiao-dong Zhuang at 1 site in China.
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 7 inclusion and 16 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 7 Feb 2025. 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 China. 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 Xiao-dong Zhuang MD (+8613760755035, zhuangxd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amounts of new lesions (time frame: 72 hours). 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 7 Feb 2025.