Atrial Fibrillation Mitral Valve InsufficiencyNCT07741383
A Study on the Efficacy and Safety of TEER Combined With Electrical Cardioversion in Patients With Severe Mitral Regurgitation and Atrial Fibrillation
A study testing TEER and Electrical Cardioversion in people with Atrial Fibrillation Mitral Valve Insufficiency, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of combined electrical cardioversion and TEER in patients with severe mitral regurgitation and atrial fibrillation after undergoing TEER. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Mitral Valve Insufficiency
- What is being tested?
- TEER and Electrical Cardioversion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2026to 31 Dec 2029
- 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
- Age ≥ 18 years;
- Successful TEER procedure with residual mitral regurgitation grade < 2+;
- No left atrial thrombus, no severe cardiomyopathy, left atrial anteroposterior diameter < 5.5 cm, and anatomically suitable for electrical cardioversion;
- Ability to understand the study objectives, voluntarily sign the informed consent form, and willingness to comply with required examinations and clinical follow-up.
Who cannot join
- 1. Left ventricular ejection fraction < 20%; 2. Stroke or transient ischemic attack within 30 days; 3. Contraindication to anticoagulants, antiplatelet agents, or antiarrhythmic drugs; 4. Severe diseases that may interfere with treatment evaluation, such as severe neurological impairment affecting cognitive function, malignant tumors, etc.; 5. Life expectancy < 12 months; 6. Any other anatomical, concomitant disease, medical, social, or psychological condition that, in the investigator's judgment, may limit the participant's ability to comply with study requirements or affect the scientific validity of the study results.
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
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Yaping Wang, 86-13805725837, yapingwang@zju.edu.cn
About this study
Official title: A Study on the Efficacy and Safety of TEER Combined Electrical Cardioversion in Patients With Severe Mitral Regurgitation and Atrial Fibrillation: A Prospective, Multicenter, Open-Label Randomized Controlled Study
This study aims to evaluate the safety and efficacy of combined electrical cardioversion and TEER in patients with severe mitral regurgitation and atrial fibrillation after undergoing TEER. The main objective is to assess the superiority of the combined treatment strategy in reducing the composite endpoints of all-cause mortality, re-hospitalization for heart failure, and stroke within one year, providing high-quality evidence-based medical evidence to optimize the "structural repair + rhythm control" comprehensive intervention strategy for such patients.
- Being tested
- TEER and Electrical Cardioversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEER and Electrical CardioversionProcedure or surgery
Transcatheter Edge-to-Edge Repair (TEER) followed by immediate electrical cardioversion (ECV) during the same procedure. ECV is performed with synchronized shock at 100-200J, preceded by intravenous amiodarone 300mg. If the first shock fails, a repeated shock up to 200J may be attempted. All patients receive guideline-directed medical therapy (GDMT), anticoagulation, and antiarrhythmic drugs per standard practice.
| Study group | Role | What they receive |
|---|---|---|
| TEER + Electrical Cardioversion | Experimental | Not described Receives: Procedure: TEER and Electrical Cardioversion |
| TEER Alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-Cause Death, Heart Failure Rehospitalization, and Stroke
Composite endpoint consisting of: 1) all-cause death (cardiovascular or non-cardiovascular); 2) heart failure rehospitalization, defined as unplanned hospital stay of ≥24 hours due to new or worsening signs/symptoms of heart failure requiring intravenous diuretics, vasoactive therapy, or mechanical support (e.g., IABP, ultrafiltration); and 3) stroke (ischemic, hemorrhagic, or undetermined), confirmed by a neurologist and/or neuroimaging. All events are independently adjudicated by the Clinical Events Committee (CEC) in a blinded manner according to M-VARC definitions.
Measured: Within 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start14 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741383
- Sponsor's protocol ID
- 2026-1111
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of TEER Combined Electrical Cardioversion in Patients With Severe Mitral Regurgitation and Atrial Fibrillation: A Prospective, Multicenter, Open-Label Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07741383
- Acronym / sponsor ID
- 2026-1111
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Aug 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.
This study aims to evaluate the safety and efficacy of combined electrical cardioversion and TEER in patients with severe mitral regurgitation and atrial fibrillation after undergoing TEER. The main objective is to assess the superiority of the combined treatment strategy in reducing the composite endpoints of all-cause mortality, re-hospitalization for heart failure, and stroke within one year, providing high-quality evidence-based medical evidence to optimize the "structural repair + rhythm control" comprehensive intervention strategy for such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEER + Electrical Cardioversion | Experimental | Procedure: TEER and Electrical Cardioversion |
| TEER Alone | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Successful TEER procedure with residual mitral regurgitation grade < 2+;
- No left atrial thrombus, no severe cardiomyopathy, left atrial anteroposterior diameter < 5.5 cm, and anatomically suitable for electrical cardioversion;
- Ability to understand the study objectives, voluntarily sign the informed consent form, and willingness to comply with required examinations and clinical follow-up.
Key exclusion criteria (1 listed)
- 1. Left ventricular ejection fraction < 20%; 2. Stroke or transient ischemic attack within 30 days; 3. Contraindication to anticoagulants, antiplatelet agents, or antiarrhythmic drugs; 4. Severe diseases that may interfere with treatment evaluation, such as severe neurological impairment affecting cognitive function, malignant tumors, etc.; 5. Life expectancy < 12 months; 6. Any other anatomical, concomitant disease, medical, social, or psychological condition that, in the investigator's judgment, may limit the participant's ability to comply with study requirements or affect the scientific validity of the study results.
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 |
|---|---|---|
| TEER and Electrical CardioversionTranscatheter Edge-to-Edge Repair (TEER) followed by immediate electrical cardioversion (ECV) during the same procedure. ECV is performed with synchronized shock at 100-200J, preceded by intravenous amiodarone 300mg. If the first shock fails, a repeated shock up to 200J may be attempted. All patients receive guideline-directed medical therapy (GDMT), anticoagulation, and antiarrhythmic drugs per standard practice. | Procedure or surgery | TEER + Electrical Cardioversion |
Primary outcome
Composite of All-Cause Death, Heart Failure Rehospitalization, and Stroke
Time frame: Within 12 months post-randomization
Composite endpoint consisting of: 1) all-cause death (cardiovascular or non-cardiovascular); 2) heart failure rehospitalization, defined as unplanned hospital stay of ≥24 hours due to new or worsening signs/symptoms of heart failure requiring intravenous diuretics, vasoactive therapy, or mechanical support (e.g., IABP, ultrafiltration); and 3) stroke (ischemic, hemorrhagic, or undetermined), confirmed by a neurologist and/or neuroimaging. All events are independently adjudicated by the Clinical Events Committee (CEC) in a blinded manner according to M-VARC definitions.
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 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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 TEER and Electrical Cardioversion in people with Atrial Fibrillation Mitral Valve Insufficiency, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. 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 Jianan Wang (0571-87784804, wangjianan111@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-Cause Death, Heart Failure Rehospitalization, and Stroke (time frame: Within 12 months post-randomization). 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 3 Aug 2026.