This study specifically targets atrial functional mitral regurgitation (AFMR)—a functional mitral valve regurgitation caused by annular dilatation and inadequate leaflet coaptation secondary to atrial fibrillation or atrial enlargement, rather than primary valvular pathology.
Conditions
Interventions
Strict rate-control group:Pharmacological heart-rate control aiming for a resting heart rate <70 bpm and <110 bpm during moderate exertion (6-minute walk test).
Lenient rate-control group:Pharmacological heart-rate control targeting <100 beats per minute
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pre-operative clinical and echocardiographic criteria consistent with atrial functional mitral regurgitation (AFMR) and MR grade >= 3+; 2.Pre-operative diagnosis of persistent atrial fibrillation; 3. The cardiac team assessed that the patient was suitable for transcatheter edge to edge repair (Teer) treatment, and the patient agreed and accepted Teer; 3.Pre-operative mean resting heart rate >= 70 bpm, irrespective of rate-control medication use; 4.Successful TEER procedure: intra-operative transesophageal echocardiography (TEE) immediately after device deployment and before surgical closure documents residual MR <= 2+; 5.Stable post-TEER status: absence, between the procedure and enrollment, of any new clinical events that could interfere with implementation of the assigned rate-control strategy or bias endpoint assessment, specifically: (1) Symptomatic bradycardia or high-degree atrioventricular block requiring temporary pacing or causing hemodynamic instability; (2) Procedure-related major complications (e.g., myocardial infarction, stroke, cardiac tamponade);(3) Emergent, newly arising severe non-cardiac conditions; (4) Any other situation deemed by the investigator to render participation inappropriate; 6.Willingness and ability to comply with protocol-mandated visits and data-collection procedures; 7.Capacity to comprehend the study objectives; voluntary participation with written informed consent provided by the subject or legal guardian.
Exclusion criteria
Exclusion criteria: 1.Known contraindication to strict or lenient rate-control therapy (e.g., previous adverse reaction/contraindication to negative chronotropic drugs such as severe hypersensitivity, sick-sinus syndrome, or high-degree AV block); 2.Patient converted to surgical treatment; 3.Cardiac or great-vessel surgery or interventional procedure within 3 months before index TEER (diagnostic coronary angiography permitted). Specifically exclude: all open or minimally invasive cardiac operations (CABG, valvular, aortic, pericardial, surgical LAA closure, etc.) and all therapeutic percutaneous procedures including but not limited to PCI, structural interventions (TAVR, LAA occlusion, other valve interventions), catheter ablation, new implantation of pacemaker/ICD/CRT, and great-vessel stenting; 4.Any type of stroke within 1 month before the procedure; 5.Acute myocardial infarction within 1 month before the procedure; 6.Left-atrial-appendage thrombus documented on pre-procedural imaging; 7.Any known active infection; 8.Concomitant moderate-or-greater aortic-valve disease or any other valve lesion requiring intervention; 9.Current or anticipated need for pacemaker, ICD, and/or CRT implantation; 10.Untreated or persistently abnormal thyroid function >1 month, defined by any of: (1) Untreated thyrotoxicosis (clinical hyperthyroidism): TSH 1.5×ULN.(2) Untreated overt hypothyroidism: TSH >10 mIU/L AND free T4 below LLN. (3) Despite treatment, thyroid function remains as defined in (a) or (b) for >1 month. 11.Severe hepatic or renal impairment: severe hepatic dysfunction—ALT or AST >=1.5×ULN; severe renal dysfunction—eGFR <30 mL/min/1.73 m^2 or need for haemodialysis. 12.Pregnancy, breast-feeding, or intention to become pregnant during the trial; 13.Unable to walk, cycle, or tolerate exercise/activity assessment; 14.Participation in another clinical trial that has not yet reached its primary endpoint; 15.Any condition that, in the opinion of the investigator, renders the patient unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with mitral regurgitation (MR) grade <= 1+ at 1 year post-procedure.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of cardiovascular death and rehospitalization for heart failure after surgery;Percentage change from baseline in left atrial volume index (LAVI) at 1 year post-procedure.;Post-procedure cardiac function improvement indicators; | — |
Countries
China
Contacts
Public ContactHao Zhou
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed