| Registry | NCT06740539 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 304 (Estimated) |
| Sponsor | Shanghai Chest Hospital (Other); collaborators: The Third Affiliated Hospital of Anhui Medical University, Hefei Second People's Hospital, The Second People's Hospital of Anhui Province, Hefei Binhu Hospital |
| Conditions | HFpEF - Heart Failure with Preserved Ejection Fraction, Atrial Fibrillation (AF) |
| Interventions | Catheter ablation of atrial fibrillation (Procedure) |
| Dates | start 2024-12-16 (estimated), primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2024-12-18, last updated 2024-12-18 |
| Locations | 1 site in China |
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All trials for HFpEF - Heart Failure with Preserved Ejection Fraction All trials for Atrial Fibrillation (AF) All trials of Catheter ablation of atrial fibrillation
A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ablation Group | Experimental | Procedure: Catheter ablation of atrial fibrillation | Ablation Group: Received heart failure treatment combined with ablation |
| Drug Control Group | No intervention | Received heart failure treatment combined with heart rate control. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age ≥18 years. * The patient is willing and able to comply with the protocol and has provided written informed consent. * Paroxysmal or persistent atrial fibrillation (AF).(Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF is 'long-standing persistent AF', defined as continuous AF of >1-year duration. AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter ECG, Loop Recorder, memory of the implanted device (ICD/CRT-D), or any other suitable device.) * Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs. * Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).((1) a history of hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg/mL for pa-tients with SR at admission and ≥600 pg/mL for patients with AF at admis-sion.) * New York Heart Association class II, III, or IV. Exclusion Criteria: * Previous left heart ablation procedure for AF. * Contraindication to chronic anticoagulation therapy or heparin. * Documented left atrial diameter >6 cm, optimally from the parasternal long-axis view. * Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment. * Planned cardiovascular intervention. * Listed for heart transplant. * Cardiac assist device implanted. * Life expectancy ≤ 12 months. * Mental or physical inability to participate in the study. * Requirement for dialysis due to terminal renal failure. * Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age. * Enrollment in another investigational drug or device study, or participation in another telemonitoring concept.
| Facility | City | Country | Status |
|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |