(123I-mIBG And Defibrillation for Atrial Fibrillation): Enhanced sympathetic activity as a mechanism of Atrial Fibrillation recurrence

(123I-mIBG And Defibrillation for Atrial Fibrillation): Enhanced sympathetic activity as a mechanism of Atrial Fibrillation recurrence - MAD-AF

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48497

Enrollment

Registered

2019-09-23

Start date

2020-12-31

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation supravertricular arrhythmia

Interventions

123I-mIBG scan

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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 scintigraphy - Arrhythmia other than atrial fibrillation as the indication for cardioversion - Emergency electrical cardioversion - Overt heart failure symptoms (i.e. edema, pulmonary rales, orthopnea), NYHA class>=2 and/or left ventricular ejection fraction 50% stenosis) - Myocardial infarction or acute coronary syndrome within 3 months prior to the cardioversion - History of catheter or surgical ablation for any arrhythmia - CVA within 6 months prior to the cardioversion - Active malignant disease - History of neurosecretory tumors - 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

Design outcomes

Primary

Measure	Time frame
Documented recurrence of atrial fibrillation (or other atrial arrhythmias lasting longer than 30 seconds as per HRS/EHRA/ECAS consensus document definition) within the first 6 months after cardioversion.	—

Secondary

Measure	Time frame
AF recurrence within the first year after cardioversion (documented as stated above) Quality of life (SF-36) before and at 6 and 12 months after cardioversion Hospitalization for atrial arrhythmias Hospitalization for heart failure	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)