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Enhanced sympathetic activity as a mechanism of Atrial Fibrillation

Enhanced sympathetic activity as a mechanism of Atrial Fibrillation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22645
Enrollment
30
Registered
2020-01-29
Start date
2020-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Atrial fibrillation

Interventions

None listed

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

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 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 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.

Design outcomes

Primary

MeasureTime frame
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. Documentation of recurrent AF includes, but is not limited to: a)ECG documentation of AF recurrence b)Read out of pacemaker or ICD demonstrating AF c)Holter recordings demonstrating AF d)Subsequent electrical or chemical cardioversion for any supraventricular arrhythmia

Secondary

MeasureTime frame
a) AF recurrence within the first year after cardioversion (documented as stated above) b) Hospitalisation for atrial arrhythmias c) Hospitalisation for heart failure

Contacts

Public ContactJoris R. de Groot

Amsterdam UMC - Locatie AMC

j.r.degroot@amsterdamumc.nl+31205666837

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)