Atrial Fibrillation, Heart Failure, Electrical Cardioversion
Conditions
Interventions
The intervention under research in this study is an electrical cardioversion. 
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a patient must meet all of the following criteria:Male or female patients with age = 18 years Diagnosis of HF =90 days prior to screening NYHA class = 2 on guideline-directed medical therapy.ECG-confirmed AF/Aflutter at screeningReceived oral anti-coagulants for = 3 weeks (NOAC, vitamin K antagonists with an INR between 2 and 3) prior to screeningPatients eligible for both treatment strategies judged by the investigator and physician.Provide written dated informed consent for participation prior to trial admission.
Exclusion criteria
Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in this study:Inability to understand and sign informed consent formHospitalization for acute HF or worsening HF = 3 months prior to screeningHeart rate during AF/ atrial flutter = 110 bpm, despite optimal rate control therapyParoxysmal or permanent AF/atrial flutter Previous left atrial ablation or surgery = 3 months prior to screeningPlanned catheter ablation at time of screening AF due to a reversible cause (e.g. post-operative AF, hyperthyroidism)Recent acute coronary syndrome (=90 days), stroke/TIA or cardiac intervention. Cardiac interventions include percutaneous coronary intervention, coronary artery bypass grafting, and heart valve repair or replacement (endovascular or surgical)Presence of (or scheduled for) mechanical assist device or heart transplantationPatients with complex congenital heart diseasePatients with current echocardiographic evidence of severe aortic-, mitral-, tricuspid- or pulmonary- valve disease (either stenosis or regurgitation)Patients with an intracardiac thrombus Expected life span from time of enrolment of =1 year, as assessed by the clinicianPatient currently enrolled in another randomized clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of treatment alterations by the physician during 3 months post intervention/randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of ECV, recurrences of AF at 4 weeks, QoL changes assessed by AFEQT and KCCQ score, echocardiographic changes (left ventricular ejection fraction (LVEF) and cardiac output (CO)), and laboratory changes (NT-proBNP) between baseline (pre-cardioversion) and 4 weeks (post-cardioversion). Whether the physician can distinguish AF from HF symptoms and whether ECV can be used as diagnostic tool. | — |
Countries
Netherlands
Contacts
Public ContactM. Rienstra
Universitair Medisch Centrum Groningen
Outcome results
None listed