Atrial Functional Mitral RegurgitationATTRACTIONNCT07744035
Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation
A study testing Transcatheter edge to edge repair and Catheter ablation in people with Atrial Functional Mitral Regurgitation and Atrial Fibrillation (AF), run by Mao Chen.
Trial summary
This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Functional Mitral Regurgitation, Atrial Fibrillation (AF)
- What is being tested?
- Transcatheter edge to edge repair and Catheter ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 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
- Left ventricular ejection fraction ≥ 50%
- Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml)
- Valve morphology: MR originating from the mid portion of the valve; mitral valve area> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth< 11 mm, coaptation length> 2 mm
- Rate control in suspected AF-induced cardiomyopathy (heart rate <80 bpm at rest and <110 bpm during exercise)
- Patients must be willing to comply with all follow-up requirements
Who cannot join
- Life expectancy< 1 year due to non-cardiac conditions
- Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or <severe but extending into the leaflets), and/or any mixed pathology
- Active endocarditis of the mitral valve or rheumatic mitral valve disease
- Hypotension (systolic pressure < 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure> 70 mmHg
- Stroke/TIA, TAVR, CRT/ CRT-D/ ICD, cardiac intervention or surgery within 30 days before randomization
Show all 15Show fewer
- Any prior MV surgery or transcatheter procedure
- Need for any cardiac surgery (other than for MV disease)
- Untreated clinically significant coronary artery disease
- Echocardiographic evidence of intracardiac thrombus
- Active infections requiring current antibiotic therapy
- Patients who cannot tolerate anti-platelet/anticoagulation agents/contrast media
- Pregnancy
- Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with medical therapy) and follow-up visits
- Patient (or legal guardian) unable or unwilling to provide written informed consent before study enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ablation wiTh TRAnsCatheter Edge-to-edge Repair Versus ablaTION Alone for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION Study)
This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.
Read the detailed description
Rationale:
The introduction of transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation (FMR) has led to a significant reduction in mortality and heart failure hospitalizations. However, the optimal timing and intervention for patients with atrial functional mitral regurgitation (AFMR) have not been evaluated in clinical trials. Published clinical trials, including COAPT, MITRA-FR, and RESHAPE-HF, did not classify functional mitral regurgitation according to ventricular or atrial origin. Concerns regarding the role of atrial fibrillation (AF) as a potential trigger of atrial dilatation and a consequence of atrial remodeling have led to recommendations for rhythm control in selected patients. Given the high incidence of AFMR among patients with persistent AF, successful ablation and maintenance of sinus rhythm may remain challenging. Therefore, concomitant TEER and catheter ablation are hypothesized to provide greater clinical benefit compared with catheter ablation alone.
Aim:
The purpose of this study is to evaluate the efficacy of TEER combined with catheter ablation in patients with significant AFMR and AF, focusing on clinical outcomes and atrial reverse remodeling.
Study design:
Patients with moderate-to-severe or severe AFMR and AF will be enrolled in a randomized, open-label, controlled study. Patients will be randomized in a 1:1 ratio to receive TEER combined with catheter ablation or catheter ablation alone. The study duration is anticipated to include 24 months of enrollment and 12 months of follow-up.
- Being tested
- Transcatheter edge to edge repair, Catheter ablation
- Keywords
- Transcatheter edge to edge repair, Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter edge to edge repairDevice
Also called TEER
Participants will undergo catheter ablation for persistent atrial fibrillation followed by transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation during the same hospitalization. TEER will be performed using an approved transcatheter mitral valve repair system to reduce mitral regurgitation severity and improve cardiac function.
Catheter ablationProcedure or surgery
Participants will undergo catheter ablation for persistent atrial fibrillation during the study period. The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| TEER+Ablation | Experimental | Patients will undergo catheter ablation and transcatheter edge to edge repair. Receives: Device: Transcatheter edge to edge repair; Procedure: Catheter ablation |
| Catheter ablation | Active comparator | Patients will undergo catheter ablation only. Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Composite Clinical Endpoint (Win Ratio)
The primary endpoint is a single hierarchical composite clinical endpoint analyzed by pairwise comparison. Each participant in the transcatheter edge-to-edge repair (TEER) plus catheter ablation group is compared with each participant in the catheter ablation alone group, in order of clinical priority: all-cause mortality, cumulative cardiovascular-related hospitalization, atrial fibrillation recurrence, and change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Each pairwise comparison is resolved at the highest-priority component that differs between the two participants, and results in a single "win," "loss," or "tie." The treatment effect is summarized as one win ratio, defined as the total number of wins divided by the total number of losses across all pairs, comparing the TEER plus catheter ablation group with the catheter ablation alone group.
Measured: 12 months
Secondary outcomes (11)
Incidence of 30-day composite safety events
The composite safety endpoint includes cardiovascular mortality, stroke, myocardial infarction, acute kidney injury, major bleeding, and non-elective cardiovascular surgery for device-related complications within 30 days after the procedure.
Measured: 30 days
Change in mitral regurgitation grade from baseline
Mitral regurgitation severity will be assessed by transthoracic echocardiography according to an integrated approach recommended by current guidelines. The outcome will be the proportion of patients achieving mild or less mitral regurgitation (grade ≤2) at 12 months.
Measured: 12 months
Composite of all-cause mortality and cardiovascular-related hospitalization
The composite endpoint includes all-cause mortality and cardiovascular-related hospitalization within 12 months. Death events will be identified through follow-up records, and cardiovascular-related hospitalizations will be confirmed by medical record review according to predefined criteria.
Measured: 12 months
Cardiovascular mortality
Cardiovascular mortality is defined as death caused by cardiovascular causes and will be determined through review of medical records and clinical documentation.
Measured: 12 months
Heart failure hospitalizations
Heart failure hospitalization is defined as an unplanned admission lasting ≥24 hours due to acute decompensated heart failure, with symptoms, signs, and/or laboratory evidence of heart failure and requiring intravenous or mechanical heart failure therapies. Events will be identified through medical records and adjudicated according to predefined criteria.
Measured: 12 months
Incidence of stroke or transient ischemic attack
Stroke and transient ischemic attack events will be identified through clinical assessment, medical records, and neuroimaging findings. Stroke will be classified as ischemic or hemorrhagic according to clinical diagnosis and imaging evaluation.
Measured: 12 months
Change in left atrial volume index
Left atrial volume index is assessed by the biplane method of disks and indexed to body surface area.
Measured: 12 months
Change in left atrial reservoir function from baseline
Left atrial reservoir function will be assessed using speckle-tracking echocardiography, and the change from baseline to 12 months will be evaluated.
Measured: 12 months
Change in severity of tricuspid regurgitation from baseline
Tricuspid regurgitation severity will be assessed by transthoracic echocardiography using an integrated approach according to current guidelines. The change in tricuspid regurgitation severity from baseline to 12 months will be evaluated.
Measured: 12 months
Change in NYHA functional classification from baseline
The New York Heart Association (NYHA) functional class will be assessed by clinical evaluation based on patients' symptoms and limitations during physical activity. The change from baseline to 12 months will be evaluated.
Measured: 12 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline
Plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels will be measured using standard laboratory assays. The change from baseline to 12 months will be evaluated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial Functional 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
- Model description
- The experimental group will undergo transcatheter edge-to-edge repair plus catheter ablation, while the controlled group will undergo only catheter ablation.
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mao Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Mao Chen, West China Hospital
- Investigators
- Mao Chen, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744035
- Sponsor's protocol ID
- 2026-286
- Acronym
- ATTRACTION
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Genereux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium. Eur Heart J. 2015 Aug 1;36(29):1851-77. doi: 10.1093/eurheartj/ehv281. Epub 2015 Jul 13.
PubMed 26170467Wunderlich NC, Siegel RJ. Peri-interventional echo assessment for the MitraClip procedure. Eur Heart J Cardiovasc Imaging. 2013 Oct;14(10):935-49. doi: 10.1093/ehjci/jet060.
PubMed 24062377Farhan S, Silbiger JJ, Halperin JL, Zhang L, Dukkipati SR, Vogel B, Kini A, Sharma S, Lerakis S. Pathophysiology, Echocardiographic Diagnosis, and Treatment of Atrial Functional Mitral Regurgitation: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Dec 13;80(24):2314-2330. doi: 10.1016/j.jacc.2022.09.046.
PubMed 36480974Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.
PubMed 30145927Stone GW, Abraham WT, Lindenfeld J, Kar S, Grayburn PA, Lim DS, Mishell JM, Whisenant B, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Asch FM, Mack MJ; COAPT Investigators. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.
PubMed 36876756
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation wiTh TRAnsCatheter Edge-to-edge Repair Versus ablaTION Alone for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION Study)
- ClinicalTrials.gov ID
- NCT07744035
- Acronym / sponsor ID
- ATTRACTION / 2026-286
- Keywords
- Transcatheter edge to edge repair, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Mao ChenUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 4 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 trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.
Detailed description
Rationale:
The introduction of transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation (FMR) has led to a significant reduction in mortality and heart failure hospitalizations. However, the optimal timing and intervention for patients with atrial functional mitral regurgitation (AFMR) have not been evaluated in clinical trials. Published clinical trials, including COAPT, MITRA-FR, and RESHAPE-HF, did not classify functional mitral regurgitation according to ventricular or atrial origin. Concerns regarding the role of atrial fibrillation (AF) as a potential trigger of atrial dilatation and a consequence of atrial remodeling have led to recommendations for rhythm control in selected patients. Given the high incidence of AFMR among patients with persistent AF, successful ablation and maintenance of sinus rhythm may remain challenging. Therefore, concomitant TEER and catheter ablation are hypothesized to provide greater clinical benefit compared with catheter ablation alone.
Aim:
The purpose of this study is to evaluate the efficacy of TEER combined with catheter ablation in patients with significant AFMR and AF, focusing on clinical outcomes and atrial reverse remodeling.
Study design:
Patients with moderate-to-severe or severe AFMR and AF will be enrolled in a randomized, open-label, controlled study. Patients will be randomized in a 1:1 ratio to receive TEER combined with catheter ablation or catheter ablation alone. The study duration is anticipated to include 24 months of enrollment and 12 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group will undergo transcatheter edge-to-edge repair plus catheter ablation, while the controlled group will undergo only catheter ablation.
| Arm | Type | Receives |
|---|---|---|
| TEER+Ablation | Experimental | Device: Transcatheter edge to edge repair, Procedure: Catheter ablationPatients will undergo catheter ablation and transcatheter edge to edge repair. |
| Catheter ablation | Active comparator | Procedure: Catheter ablationPatients will undergo catheter ablation only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Left ventricular ejection fraction ≥ 50%
- Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml)
- Valve morphology: MR originating from the mid portion of the valve; mitral valve area> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth< 11 mm, coaptation length> 2 mm
- Rate control in suspected AF-induced cardiomyopathy (heart rate <80 bpm at rest and <110 bpm during exercise)
Key exclusion criteria (15 listed)
- Life expectancy< 1 year due to non-cardiac conditions
- Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or <severe but extending into the leaflets), and/or any mixed pathology
- Active endocarditis of the mitral valve or rheumatic mitral valve disease
- Hypotension (systolic pressure < 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure> 70 mmHg
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 |
|---|---|---|
| Transcatheter edge to edge repairAlso: TEERParticipants will undergo catheter ablation for persistent atrial fibrillation followed by transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation during the same hospitalization. TEER will be performed using an approved transcatheter mitral valve repair system to reduce mitral regurgitation severity and improve cardiac function. | Device | TEER+Ablation |
| Catheter ablationParticipants will undergo catheter ablation for persistent atrial fibrillation during the study period. The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated. | Procedure or surgery | Catheter ablation, TEER+Ablation |
Primary outcome
Hierarchical Composite Clinical Endpoint (Win Ratio)
Time frame: 12 months
The primary endpoint is a single hierarchical composite clinical endpoint analyzed by pairwise comparison. Each participant in the transcatheter edge-to-edge repair (TEER) plus catheter ablation group is compared with each participant in the catheter ablation alone group, in order of clinical priority: all-cause mortality, cumulative cardiovascular-related hospitalization, atrial fibrillation recurrence, and change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Each pairwise comparison is resolved at the highest-priority component that differs between the two participants, and results in a single "win," "loss," or "tie." The treatment effect is summarized as one win ratio, defined as the total number of wins divided by the total number of losses across all pairs, comparing the TEER plus catheter ablation group with the catheter ablation alone group.
11 secondary outcomes
Incidence of 30-day composite safety events
Time frame: 30 days
Change in mitral regurgitation grade from baseline
Time frame: 12 months
Composite of all-cause mortality and cardiovascular-related hospitalization
Time frame: 12 months
Cardiovascular mortality
Time frame: 12 months
Heart failure hospitalizations
Time frame: 12 months
Incidence of stroke or transient ischemic attack
Time frame: 12 months
Change in left atrial volume index
Time frame: 12 months
Change in left atrial reservoir function from baseline
Time frame: 12 months
Change in severity of tricuspid regurgitation from baseline
Time frame: 12 months
Change in NYHA functional classification from baseline
Time frame: 12 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline
Time frame: 12 months
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 4 Aug 2026.
- Results publication: PubMed 26170467Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Genereux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium. Eur Heart J. 2015 Aug 1;36(29):1851-77. doi: 10.1093/eurheartj/ehv281. Epub 2015 Jul 13.
- Results publication: PubMed 24062377Wunderlich NC, Siegel RJ. Peri-interventional echo assessment for the MitraClip procedure. Eur Heart J Cardiovasc Imaging. 2013 Oct;14(10):935-49. doi: 10.1093/ehjci/jet060.
- Results publication: PubMed 36480974Farhan S, Silbiger JJ, Halperin JL, Zhang L, Dukkipati SR, Vogel B, Kini A, Sharma S, Lerakis S. Pathophysiology, Echocardiographic Diagnosis, and Treatment of Atrial Functional Mitral Regurgitation: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Dec 13;80(24):2314-2330. doi: 10.1016/j.jacc.2022.09.046.
- Results publication: PubMed 30145927Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.
- Results publication: PubMed 36876756Stone GW, Abraham WT, Lindenfeld J, Kar S, Grayburn PA, Lim DS, Mishell JM, Whisenant B, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Asch FM, Mack MJ; COAPT Investigators. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.
- 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.
Mao Chen principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter edge to edge repair and Catheter ablation in people with Atrial Functional Mitral Regurgitation and Atrial Fibrillation (AF), run by Mao Chen.
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 6 inclusion and 15 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 4 Aug 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 Zhengang Zhao (86-18980733914, zhaozhengang@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite Clinical Endpoint (Win Ratio) (time frame: 12 months). 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 NCT07744035, which also lists 5 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 4 Aug 2026.