Atrial Fibrillation with Heart Failure with Preserved Eje... | NCT06740539

Status Module

Name	Class
The Third Affiliated Hospital of Anhui Medical University	UNKNOWN
Hefei Second People's Hospital	UNKNOWN
The Second People's Hospital of Anhui Province	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ablation Group	Experimental	Ablation Group: Received heart failure treatment combined with ablation	Procedure: Catheter ablation of atrial fibrillation
Drug Control Group	No Intervention	Received heart failure treatment combined with heart rate control.

Name	Type	Description	Arm Group Labels	Other Names
Catheter ablation of atrial fibrillation	Procedure	Catheter ablation of atrial fibrillation	Ablation Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.	The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.	During regular follow-up visits at 3, 6, 12, 24months.

Secondary Outcomes

Measure	Description	Time Frame
All-Cause Mortality	All deaths and all heart transplants because of terminal heart failure (HF) will be included.	During regular follow-up visits at 3, 6, 12, 24months.
Worsening of Heart Failure Requiring Unplanned Hospitalization

Eligibility Module

Eligibility Criteria

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.

Name	Role	Phone	Extension	Email
Mu Qin, Dr	Contact	+8613052320103		qinmuae@163.com

Patients requiring intravenous medication for HF (including diuretics, vasodilators or inotropic agents) or a substantial increase in oral diuretic therapy for HF (i.e., an increase of furosemide ≥40 mg or equivalent, or the addition of a thiazide to a loop diuretic) will be deemed to have worsening of HF. Further, rales and/or S3 sound, chest x-ray, worsening of dyspnea, worsening of peripheral edema and increase of New York Heart Association class will be assessed for determination of worsening of HF.Unplanned hospitalization is defined as any in-hospital stay over one date change, and not planned by the Investigator.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms