Prospective oBsErvatioNal study of the EFfect of catheter ablatIon among patienTs with Heart Failure with Preserved Ejection Fraction and persistent atrial fibrillatio
- Conditions
- Patients with heart failure with preserved ejection fraction and persistent atrial fibrillation
- Registration Number
- JPRN-UMIN000042364
- Lead Sponsor
- agoya University Graduate School of Medicine, Department of Cardiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
A. Left atrium diameter> 60mm B. Contraindications for anticoagulant therapy or heparin C. History of ablation to previous AF D. Acute coronary syndrome, emergency coronary artery reconstruction, heart surgery, major vascular surgery, TIA, stroke within the last 3 months E. Coronary artery reconstruction within 1 last month F. Acute heart failure requiring treatment with diuretics, vasodilators, inotropes, etc. within 1 month (including additional outpatient treatment) G. Plan for coronary artery reconstruction, heart surgery, and major vascular surgery within the next 3 months H. Listed for heart transplantation, after heart transplantation, or wearing left ventricular assisted circulation I. Severe valvular disease that may be indicated for surgery J. Untreated or inadequate conditions that can affect the course of heart failure Systolic blood pressure 180 mmHg or more Heart rate 110 bpm or more K. Untreated hyperthyroidism or hypothyroidism L. Findings suspected that other diseases cause symptoms of fatigue and dyspnea Severe chronic obstructive pulmonary disease (home oxygen therapy, hospitalization within 12 months, oral steroids) Pulmonary arterial hypertension Hemoglobin <10g / dL Body mass index> 40kg / m2 M. Patients with renal dysfunction or dialysis with estimated glemerular filtration rate <30 mL / min / 1.73 m2 N. Liver disease: AST or ALT is more than 3 times the standard value, or T-Bil 1.5 mg / dL or more O. Coexistence of orthopedic problems and neuromuscular diseases that are difficult to perform cardiopulmonary exercise test P. Some diseases with a predicted life prognosis of less than 3 years Q. There is a possibility that the condition may occur during pregnancy, lactation, or during a research institute. R. Medical medical conditions that may interrupt research or reduce credibility S. When other clinical studies using drugs / devices make it impossible to participate in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in peak oxygen uptake between before and 6 months of ablation
- Secondary Outcome Measures
Name Time Method Improvement of QOL, change of CPX parameters other than peakVO2, change of NT-proBNP value, change of echocardiography parameters, number of hospitalizations for heart failure, mortality rate, recurrence rate of atrial fibrillation