Enhanced sympathetic activity as a mechanism of Atrial Fibrillatio
- Conditions
- Atrial fibrillation
- Registration Number
- NL-OMON22645
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Elective cardioversion is planned
-Adequate anticoagulation with vitamin K antagonists or NOACs for at least 3 weeks prior to the procedure
-Beta-blocker use at baseline, at least continued up to the second 123I-mIBG scintigraphy
-Age between 18 and 80 years
-Legally competent and willing and able to sign informed consent
-Willing and able to conform to the study protocol
-Unable or unwilling to comply with study procedures
-Discontinuing of beta-blockers during follow-up period up to the second 123I-mIBG scintigraphy
-Discontinuing or switch of antiarrhythmic drugs during follow-up period up to the second 123I-mIBG scintigraphyArrhythmia other than AF as the indication for cardioversion
-Emergency electrical cardioversion
-Overt heart failure symptoms (i.e. oedema, pulmonary rales, orthopnoea), NYHA class=2 and/or left ventricular ejection fraction < 35%
-Known significant coronary artery disease (>50% stenosis)
-Myocardial infarction or acute coronary syndrome within 3 months prior to the cardioversion
-History of catheter or surgical ablation for any arrhythmia
-A history of a thoracotomy
-CVA within 6 months prior to the cardioversion
-Active malignant disease
-History of neurosecretory tumours
-Pregnancy or of childbearing potential without adequate contraception
-History of previous radiation therapy of the thorax
-Circumstances that prevent follow-up (no permanent home or address, transient, etc.)
-Life expectancy <2 years.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Documented recurrence of AF (or other atrial arrhythmias lasting longer than 30 seconds as per HRS/EHRA/ECAS consensus document definition) within the first 12 months after cardioversion.<br>Documentation of recurrent AF includes, but is not limited to:<br>a)ECG documentation of AF recurrence<br>b)Read out of pacemaker or ICD demonstrating AF<br>c)Holter recordings demonstrating AF<br>d)Subsequent electrical or chemical cardioversion for any supraventricular arrhythmia
- Secondary Outcome Measures
Name Time Method a)AF recurrence within the first year after cardioversion (documented as stated above)<br>b)Hospitalisation for atrial arrhythmias<br>c)Hospitalisation for heart failure