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

Phase 4

• Conditions: atrial fibrillation; supravertricular arrhythmia; 10007521

• Registration Number: NL-OMON48497
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 35

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

- 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 < 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
- 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 <2 years.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Documented recurrence of atrial fibrillation (or other atrial arrhythmias<br /><br>lasting longer than 30 seconds as per HRS/EHRA/ECAS consensus document<br /><br>definition) within the first 6 months after cardioversion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>AF recurrence within the first year after cardioversion (documented as stated<br /><br>above)<br /><br>Quality of life (SF-36) before and at 6 and 12 months after cardioversion<br /><br>Hospitalization for atrial arrhythmias<br /><br>Hospitalization for heart failure</p><br>