Mitral RegurgitationNCT06684171
Comparison of Transcatheter Edge-to-edge Repair Using Echo Only with Echo Combined with X Ray for Mitral Regurgitation (ECHO-CLIP)
A study testing Echocardiographic guidance and Fluoroscopic guidance in people with Mitral Regurgitation, run by Pan Xiangbin at 1 site in China.
Trial summary
Mitral regurgitation (MR) is a common valvular heart disease in the elderly population, frequently associated with poor prognosis if not treated. Transcatheter edge-to-edge repair (TEER) has recently emerged as a popular strategy due to minimal invasiveness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Echocardiographic guidance and Fluoroscopic guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2024to 31 Oct 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects meet either the first or second inclusion criteria in combination with the third and fourth ones were eligible.
- Symptomatic DMR subjects with MR ≥ 3+ at high surgical risk in terms of STS Predicted Risk of Mortality replacement score ≥ 8 or STS Predicted Risk of Mortality repair score ≥ 6.*
- FMR subjects with LVESD ≤ 70 mm and MR ≥ 3+, despite administration of GDMT for 30 days.*
- MV anatomy appropriate for TEER procedure.
- Subjects willing to participate in this study and complete the follow-up on schedule after obtaining informed consent.
Who cannot join
- Myocardial infarction within 12 weeks prior to randomization.
- Need for concurrent other cardiac procedures.
- Any endovascular intervention or surgery within 30 days prior to randomization.
- LVEF < 20%.
- MV orifice area < 4.0 cm2.
- Pulmonary artery systolic pressure > 70 mmHg, as determined by echocardiogram.
Show all 13Show fewer
- Severe mitral annular calcification.
- Unsuitable MV anatomy potentially precluding clip implantation: leaflet calcification or significant leaflet cleft in the grasping zone.
- Previous MV surgery or current implanted ventricular assist device or current implanted mechanical prosthetic valve.
- Any intracardiac mass, thrombus, or vegetation, as evidenced by echocardiogram.
- Active endocarditis or rheumatic heart disease.
- History of DVT or PE.
- Abbreviations: DMR, degenerative mitral regurgitation; MR, mitral regurgitation; STS, Society of Thoracic Surgeons; FMR, functional mitral regurgitation; LVESD, left ventricular end-systolic diameter; GDMT, guideline-directed medical therapy; TEER, transcatheter edge-to-edge repair; LVEF, left ventricular ejection fraction; MV, mitral valve; DVT, deep venous thrombosis; PE, pulmonary embolism.
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, 1 recruiting
- Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen
Shenzhen, Guangdong, 518000
Xiangbin Pan, 86-0755-82180028, panxiangbin@fuwaihospital.org
Fuwai Hospital Fuwai Hospital，Chinese Academy of Medical Sciences
About this study
Official title: A Randomized Clinical Trial of Transcatheter Edge-to-edge Repair for Mitral Regurgitation Under Fully Echocardiographic Guidance Compared with Under Combined Guidance of Both Echocardiography and Fluoroscopy (ECHO-CLIP Study)
Mitral regurgitation (MR) is a common valvular heart disease in the elderly population, frequently associated with poor prognosis if not treated. Transcatheter edge-to-edge repair (TEER) has recently emerged as a popular strategy due to minimal invasiveness. What's more, previous studies, such as EVEREST II and COAPT study, have demonstrated its efficacy in high-risk patients with primary or secondary MR. Conventional TEER procedure, however, is performed under combined guidance of both echocardiography and fluoroscopy, which potentially results in high radiation exposure and limits its application. Since 2021 2021, the investigators have changed the procedural methodology by performing TEER under full echocardiographic guidance on accumulated dozens of MR patients successfully. To confirm the efficacy of a fully echo-guided TEER procedure, the investigators conduct the ECHO-CLIP study to compare its outcomes with the conventional TEER procedure, as well as evaluate the outcomes of this novel methodology in special populations with radiation contraindications. ECHO-CLIP study is a prospective, multicenter, open-label, noninferior, randomized controlled trial of TEER by two different methodological strategies in treating severe primary or secondary MR. It is anticipated to enroll a total of 200 patients as well to complete the enrollment before Dec 31, 2025 and the follow-up before Dec 31, 2026. This work will potentially demonstrate the feasibility and efficacy of the fully echo-guided TEER procedure, thereby revolutionizing the TEER methodology and benefiting more patients.
- Conditions
- Mitral Regurgitation
- Being tested
- Echocardiographic guidance, Fluoroscopic guidance
- Keywords
- mitral regurgitation, transcatheter edge-to-edge repair, ECHO-CLIP, randomized clinical trail, ultrasound, echo
- 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.
Echocardiographic guidanceProcedure or surgery
After detailed evaluation, patients randomized in this group will undergo TEER procedure under guidance of fully echocardiography but any fluoroscopy in the entire process.
Fluoroscopic guidanceProcedure or surgery
After detailed evaluation, patients randomized in this group will undergo TEER procedure under combined guidance of echocardiography and fluoroscopy in the entire process.
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography-guided group | Experimental | Patients randomized to the echocardiography-guided group will undergo TEER procedure under fully echo guidance. Receives: Procedure: Echocardiographic guidance |
| Fluoroscopy-guided group | Active comparator | Patients randomized to the fluoroscopy-guided group will undergo TEER procedure under combined guidance of X ray and echo. Receives: Procedure: Fluoroscopic guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day successful rate after device implantation (residual MR ≤2+)
The primary outcome is the success rate of device implantation at 30 days ( residual MR≤moderate). Evaluation of the primary endpoints was done by specialized sonographers blinded to the intervention.
Measured: At 30 days after device implantation
Secondary outcomes (29)
1-year all-cause mortality
All-cause mortality at 1 year after implantation.
Measured: At 1 year after implantation
1-year composite of death, reintervention, and recurrent MR ≥ 3+
Composite of death, reintervention, and recurrent MR ≥ 3+ at 1 year
Measured: At 1 year after implantation
Change in SF-36 score from baseline to 30 days and 1 year.
Change in 36-Item Short Form Survey score from baseline to 30 days and 1 year will be assessed. An increased score after implantation indicates an improvement in quality of life, while a decreased score after implantation indicates an impairment in quality of life.
Measured: At 30 days and 1 year after implantation
Change in KCCQ score from baseline to 30 days and 1 year.
Change in Kansas City Cardiomyopathy Questionnaire score from baseline to 30 days and 1 year wiil be assessed. An increased score after implantation indicates an improvement in quality of life, while a decreased score after implantation indicates an impairment in quality of life.
Measured: At 30 days and 1 year after implantation
Change in HADS score from baseline to 30 days and 1 year.
Change in Hospital Anxiety and Depression Scale score from baseline to 30 days and 1 year will be assessed. An increased score after implantation indicates an aggregation in psychological stress, while a decreased score after implantation indicates an improvement in psychological stress.
Measured: At 30 days and 1 year after implantation
Composite of major adverse events
Composite of major adverse events immediately after implantation, at 30 days, 3 months, and at 1 year including death, myocardial infarction, reintervention, nonelective cardiovascular surgery for adverse events, ventilation over 48 hours, gastrointestinal complications requiring surgery, new-onset permanent atrial fibrillation, sepsis, and transfusion of 2 or more units of blood.
Measured: Immediately after implantation, at 30 days, 3 months, and at 1 year
Left ventricular ejection fraction
Left ventricular ejection fraction at 30 days, 3 months, and 1 year
Measured: At 30 days, 3 months, and 1 year after implantation
Left ventricular end-diastolic volume and left ventricular end-systolic volume
Left ventricular end-diastolic volume and left ventricular end-systolic volume at 30 days, 3 months, and 1 year after implantation.
Measured: At 30 days, 3 months, and 1 year after implantation.
Left ventricular end-systolic diameter and left ventricular end-diastolic diameter
Left ventricular end-systolic diameter and left ventricular end-diastolic diameter at 30 days, 3 months, and 1 year after implantation
Measured: At 30 days, 3 months, and 1 year after implantation
NYHA functional classification
At 30 days, 3 months, and 1 year after implantation.
Measured: At 30 days, 3 months, and 1 year after implantation.
Regurgitant volume and regurgitant fraction
Regurgitant volume and regurgitant fraction at 30 days, 3 months, and 1 year.
Measured: At 30 days, 3 months, and 1 year after implantation
Device implantation rate
Device implantation rate.
Measured: At 30 days after device implantation
Vascular complications
Vascular complications at 30 days, 3 months, and 1 year including access-site hematoma > 6 cm, arteriovenous fistula, symptomatic peripheral ischemia or nerve injury with symptoms or signs over 48 hours, access-site vascular injury requiring surgical repair, PE, ipsilateral DVT, access-site associated infection requiring antibiotics injection or prolonging hospital stay.
Measured: At 30 days, 3 months, and 1 year after implantation
Major bleeding events
Major bleeding events at 30 days, 3 months, and at 1 year after implantation that is defined as any procedure-related bleeding requiring transfusion of 2 or more units of blood and/or surgical repair
Measured: At 30 days, 3 months, and at 1 year after implantation
Arrhythmia
Arrhythmia at 30 days, and at 1 year after implantation
Measured: At 30 days and 1 year after implantation
Infective Endocarditis
Infective Endocarditis at 30 days, 3 months, and at 1 year after implantation according to the Duke Criteria.
Measured: At 30 days, 3 months and 1 year after implantation
Thrombotic events
Thrombotic events at 30 days, 3 months, and at 1 year after implantation.
Measured: At 30 days, 3 months, and at 1 year after implantation
Hemolytic events
Hemolytic events at 30 days, 3 months, and at 1 year after implantation.
Measured: At 30 days, 3 months, and at 1 year after implantation
Iatrogenic atrial septal defect
Iatrogenic ASD at 30 days, 3 months, and at 1 year after implantation.
Measured: At 30 days, 3 months, and at 1 year after implantation.
Single leaflet device attachment
Single leaflet device attachment at 30 days, 3 months, and at 1 year after implantation.
Measured: At 30 days, 3 months, and at 1 year after implantation.
Mitral Stenosis
Mitral stenosis at 30 days, 3 months, and at 1 year after implantation that is defined as mitral valve area < 1.5 cm2.
Measured: At 30 days, 3 months, and at 1 year after implantation.
Mitral valve area
Mitral valve area at 30 days, 3 months, and at 1 year after implantation.
Measured: At 30 days, 3 months, and at 1 year after implantation.
Transmitral pressure gradient
Transmitral pressure gradient at 30 days, 3 months, and at 1 year after implantation
Measured: At 30 days, 3 months, and at 1 year after implantation
Hospital stay after implantation
Hospital stay after implantation
Measured: At study completion with an average of 1 year
ICU stay after implantation
ICU stay after implantation
Measured: At study completion with an average of 1 year
30-day rehospitalization for heart failure
Rehospitalization for heart failure at 30 days after implantation
Measured: At 30 days after implantation
New Warfarin Use
New Warfarin Use at 30 days and 1 year after device Implantation
Measured: At 30 days and 1 year after implantation
Hospital cost
Hospital cost
Measured: At study completion with an average of 1 year
Procedure time and radiation time
Procedure time and radiation time
Measured: At study completion with an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start29 Mar 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pan Xiangbin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiangbin Pan, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684171
- Sponsor's protocol ID
- NO.SP2024005(01)A
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma J, Wang C, Wang S, Fang F, Zhang F, Yan X, Tang Y, Ouyang W, Pan X, Wang C. Design and Rationale of ECHO-CLIP Study: Transcatheter Edge-to-Edge Repair for Mitral Regurgitation Under Solely Transesophageal Echocardiographic Guidance Compared With Fluoroscopic and Transesophageal Echocardiographic Coguidance. J Am Heart Assoc. 2025 Jul;14(13):e040672. doi: 10.1161/JAHA.124.040672. Epub 2025 Jun 27.
PubMed 40576040
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Transcatheter Edge-to-edge Repair for Mitral Regurgitation Under Fully Echocardiographic Guidance Compared with Under Combined Guidance of Both Echocardiography and Fluoroscopy (ECHO-CLIP Study)
- ClinicalTrials.gov ID
- NCT06684171
- Acronym / sponsor ID
- NO.SP2024005(01)A
- Conditions
- Mitral Regurgitation
- Keywords
- mitral regurgitation, transcatheter edge-to-edge repair, ECHO-CLIP, randomized clinical trail, ultrasound, echo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pan XiangbinUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 12 Nov 2024 (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.
Mitral regurgitation (MR) is a common valvular heart disease in the elderly population, frequently associated with poor prognosis if not treated. Transcatheter edge-to-edge repair (TEER) has recently emerged as a popular strategy due to minimal invasiveness. What's more, previous studies, such as EVEREST II and COAPT study, have demonstrated its efficacy in high-risk patients with primary or secondary MR. Conventional TEER procedure, however, is performed under combined guidance of both echocardiography and fluoroscopy, which potentially results in high radiation exposure and limits its application. Since 2021 2021, the investigators have changed the procedural methodology by performing TEER under full echocardiographic guidance on accumulated dozens of MR patients successfully. To confirm the efficacy of a fully echo-guided TEER procedure, the investigators conduct the ECHO-CLIP study to compare its outcomes with the conventional TEER procedure, as well as evaluate the outcomes of this novel methodology in special populations with radiation contraindications. ECHO-CLIP study is a prospective, multicenter, open-label, noninferior, randomized controlled trial of TEER by two different methodological strategies in treating severe primary or secondary MR. It is anticipated to enroll a total of 200 patients as well to complete the enrollment before Dec 31, 2025 and the follow-up before Dec 31, 2026. This work will potentially demonstrate the feasibility and efficacy of the fully echo-guided TEER procedure, thereby revolutionizing the TEER methodology and benefiting more patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echocardiography-guided group | Experimental | Procedure: Echocardiographic guidancePatients randomized to the echocardiography-guided group will undergo TEER procedure under fully echo guidance. |
| Fluoroscopy-guided group | Active comparator | Procedure: Fluoroscopic guidancePatients randomized to the fluoroscopy-guided group will undergo TEER procedure under combined guidance of X ray and echo. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects meet either the first or second inclusion criteria in combination with the third and fourth ones were eligible.
- Symptomatic DMR subjects with MR ≥ 3+ at high surgical risk in terms of STS Predicted Risk of Mortality replacement score ≥ 8 or STS Predicted Risk of Mortality repair score ≥ 6.*
- FMR subjects with LVESD ≤ 70 mm and MR ≥ 3+, despite administration of GDMT for 30 days.*
- MV anatomy appropriate for TEER procedure.
- Subjects willing to participate in this study and complete the follow-up on schedule after obtaining informed consent.
Key exclusion criteria (13 listed)
- Myocardial infarction within 12 weeks prior to randomization.
- Need for concurrent other cardiac procedures.
- Any endovascular intervention or surgery within 30 days prior to randomization.
- LVEF < 20%.
- MV orifice area < 4.0 cm2.
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 |
|---|---|---|
| Echocardiographic guidanceAfter detailed evaluation, patients randomized in this group will undergo TEER procedure under guidance of fully echocardiography but any fluoroscopy in the entire process. | Procedure or surgery | Echocardiography-guided group |
| Fluoroscopic guidanceAfter detailed evaluation, patients randomized in this group will undergo TEER procedure under combined guidance of echocardiography and fluoroscopy in the entire process. | Procedure or surgery | Fluoroscopy-guided group |
Primary outcome
30-day successful rate after device implantation (residual MR ≤2+)
Time frame: At 30 days after device implantation
The primary outcome is the success rate of device implantation at 30 days ( residual MR≤moderate). Evaluation of the primary endpoints was done by specialized sonographers blinded to the intervention.
29 secondary outcomes
1-year all-cause mortality
Time frame: At 1 year after implantation
1-year composite of death, reintervention, and recurrent MR ≥ 3+
Time frame: At 1 year after implantation
Change in SF-36 score from baseline to 30 days and 1 year.
Time frame: At 30 days and 1 year after implantation
Change in KCCQ score from baseline to 30 days and 1 year.
Time frame: At 30 days and 1 year after implantation
Change in HADS score from baseline to 30 days and 1 year.
Time frame: At 30 days and 1 year after implantation
Composite of major adverse events
Time frame: Immediately after implantation, at 30 days, 3 months, and at 1 year
Left ventricular ejection fraction
Time frame: At 30 days, 3 months, and 1 year after implantation
Left ventricular end-diastolic volume and left ventricular end-systolic volume
Time frame: At 30 days, 3 months, and 1 year after implantation.
Left ventricular end-systolic diameter and left ventricular end-diastolic diameter
Time frame: At 30 days, 3 months, and 1 year after implantation
NYHA functional classification
Time frame: At 30 days, 3 months, and 1 year after implantation.
Regurgitant volume and regurgitant fraction
Time frame: At 30 days, 3 months, and 1 year after implantation
Device implantation rate
Time frame: At 30 days after device implantation
Vascular complications
Time frame: At 30 days, 3 months, and 1 year after implantation
Major bleeding events
Time frame: At 30 days, 3 months, and at 1 year after implantation
Arrhythmia
Time frame: At 30 days and 1 year after implantation
Infective Endocarditis
Time frame: At 30 days, 3 months and 1 year after implantation
Thrombotic events
Time frame: At 30 days, 3 months, and at 1 year after implantation
Hemolytic events
Time frame: At 30 days, 3 months, and at 1 year after implantation
Iatrogenic atrial septal defect
Time frame: At 30 days, 3 months, and at 1 year after implantation.
Single leaflet device attachment
Time frame: At 30 days, 3 months, and at 1 year after implantation.
Mitral Stenosis
Time frame: At 30 days, 3 months, and at 1 year after implantation.
Mitral valve area
Time frame: At 30 days, 3 months, and at 1 year after implantation.
Transmitral pressure gradient
Time frame: At 30 days, 3 months, and at 1 year after implantation
Hospital stay after implantation
Time frame: At study completion with an average of 1 year
ICU stay after implantation
Time frame: At study completion with an average of 1 year
30-day rehospitalization for heart failure
Time frame: At 30 days after implantation
New Warfarin Use
Time frame: At 30 days and 1 year after implantation
Hospital cost
Time frame: At study completion with an average of 1 year
Procedure time and radiation time
Time frame: At study completion with an average of 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 12 Nov 2024.
- Derived from this study: PubMed 40576040Ma J, Wang C, Wang S, Fang F, Zhang F, Yan X, Tang Y, Ouyang W, Pan X, Wang C. Design and Rationale of ECHO-CLIP Study: Transcatheter Edge-to-Edge Repair for Mitral Regurgitation Under Solely Transesophageal Echocardiographic Guidance Compared With Fluoroscopic and Transesophageal Echocardiographic Coguidance. J Am Heart Assoc. 2025 Jul;14(13):e040672. doi: 10.1161/JAHA.124.040672. Epub 2025 Jun 27.
- 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.
Xiangbin Pan principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiographic guidance and Fluoroscopic guidance in people with Mitral Regurgitation, run by Pan Xiangbin 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 5 inclusion and 13 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 12 Nov 2024. 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 Xiangbin Pan (8688396666, panxiangbin@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day successful rate after device implantation (residual MR ≤2+) (time frame: At 30 days after device implantation). 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 NCT06684171, which also lists 1 linked publication.
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 12 Nov 2024.