Persistent Atrial Fibrillation, Heart Failure With Reduced Ejection Fraction
Conditions
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.
Interventions
PROCEDUREAF ablation
The aim of the ablation procedure was to achieve isolation of all pulmonary veins and to restore sinus rhythm.Additional ablation strategies were made at the discretion of the operators.
OTHERmedical therapy
The medical therapy for atrial fibrillation was administered in accordance with the guidelines that were available at the time of the trial.Efforts to maintain sinus rhythm were recommended. The aim of the treatment was a ventricular rate of 60 to 80 beats per minute at rest.
Sponsors
Shandong University of Traditional Chinese Medicine
Yuhuan Second People's Hospital
Tongji University
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in ejection fraction between groups | Time Frame: 12 months | Difference in left ventricular ejection fraction between groups on echocardiography at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Difference in NYHA class between groups | Time Frame: 12 months |
| Difference in BNP between groups | Time Frame: 12 months |
| Difference in SR survival between groups | Time Frame: 12 months |
| Worsening heart failure requiring unplanned hospitalization | Time Frame: 12 months |
| Change in 6-minute walk distance | Time Frame: 12 months |
Countries
China
Outcome results
None listed