Clinical trial NCT05827172: AF Ablation for HF With Reduced EF
Official title: Catheter Ablation vs. Medical Treatment in Patients With HFrEF and Persistent AF (CAEFR-AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Heart Failure With Reduced Ejection Fraction
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Shandong University of Traditional Chinese Medicine
name: Yuhuan Second People's Hospital
name: Tongji University
First posted: 2023-04-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, multi-center, randomized parallel control clinical trial, to examining thethe clinical outcomes of AF ablation on HFrEF patients with persistent atrial fibrillation.

Detailed description: This is an open label, multi-center, randomized parallel control clinical trial. HFrEF patients with persistent atrial fibrillation are 1:1 randomized into the AF ablation group or the medical therapy (rate or rhythm control) group. Markers of HFrEF severity, including composite of death from any cause or worsening of heart failure that led to an unplanned overnight hospitalization,exercise hemodynamics, natriuretic peptide levels, and patient symptoms. and other indicators are analyzed to demonstrate the role of AF ablation in comparing the effects of AF ablation vs usual medical therapy for HFrEF patients with persistent atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* Symptomatic persistent atrial fibrillation Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs Left Ventricular Ejection Fraction \<= 40% NYHA \>= II Patient is willing and able to comply with the protocol and has written informed consent Age \>= 18 years Optimal therapy for HF of ≥6 weeks Suitable candidate for catheter ablation or rate control for the treatment of AF N-terminal pro-B-type natriuretic peptide (NT-proBNP)/BNP levels above predetermined levels based on prior hospitalization and baseline rhythm

Exclusion Criteria:

* LA dimension \>6.0 cm Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment Untreated hypothyroidism or hyperthyroidism Enrollment in another investigational drug or device study Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age Mental or physical inability to take part in the study Severe aortic or mitral valve disease Life expectancy \<1 year

Primary outcomes:
measure: Difference in ejection fraction between groups
timeFrame: Time Frame: 12 months
Secondary outcomes:
measure: Difference in NYHA class between groups
timeFrame: Time Frame: 12 months
measure: Difference in BNP between groups
timeFrame: Time Frame: 12 months
measure: Difference in SR survival between groups
timeFrame: Time Frame: 12 months
measure: Worsening heart failure requiring unplanned hospitalization
timeFrame: Time Frame: 12 months
measure: Change in 6-minute walk distance
timeFrame: Time Frame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: