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Clinical Trials in China / NCT06740539
Starting soon Not applicable

Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs

NCT06740539 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Chest Hospital
Phase
Not applicable
Started
2024-12-16
Last updated
2024-12-18

Condition(s) studied

HFpEF - Heart Failure with Preserved Ejection FractionAtrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

Catheter ablation of atrial fibrillation

Catheter ablation of atrial fibrillation: Catheter ablation of atrial fibrillation

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06740539 on ClinicalTrials.gov ↗ ← All trials in China