Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)
Recruiting · NCT06125925 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Medical TherapyRadiofrequency catheter ablation (RFCA)
What this trial is about
To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Symptomatic paroxysmal or persistent atrial fibrillation
- CHADS2-VASc score≥ 2
- Conform to the diagnosis of HFpEF
- NYHA II-IV level;
- Left ventricular ejection fraction (LVEF)≥ 50%;
- NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter;
- Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram.
- Sign informed consent
Exclusion criteria
- A life expectancy below 2 years due to any non-cardiovascular condition
- Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation
- Prior atrial fibrillation ablation
- Left atrial size≥ 55 mm
- Heart failure due to any of the following: known genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
- Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
- Any contraindication for radiofrequency catheter ablation, antiarrhythmic drugs or anticoagulation
- Acute coronary syndrome, cardiac surgery, angioplasty or cerebrovascular accident within 12 weeks before enrollment
- Severe hepatic and renal dysfunction
- Body mass index\> 50 kg/m2
- Female in period of pregnancy or breast-feeding
- Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
- Involved in other studies
- The inclusion and exclusion criteria would be reassessed after run-in period and the cut-off of NT-proBNP would be set as \>125 pg/ml under sinus rhythm or \>365 pg/ml under AF/atrial flutter (AFL).
Where it is running
1 location listed.
- the First Affiliated Hospital of Nanjing Medical University - Nanjing, China