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Biomarkers of reversed remodeling after electrical or pharmacological cardioversion of atrial fibrillation

Biomarkers of reversed remodeling after electrical or pharmacological cardioversion of atrial fibrillation - REVERSE AF

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42398
Enrollment
160
Registered
2016-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

arrhythmia atrial fibrillation

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Paroxysmal, persistent or longstanding persistent AF - Undergoing electrical or pharmacological cardioversion - Adequate oral anticoagulation according to guidelines with oral anticoagulants or NOACs OR - Atrial thrombosis ruled out by TEE according to guidelines - Age > 18 years. - Legally competent and willing and able to sign informed consent

Exclusion criteria

Exclusion criteria: we refer to protocol p. 12-13 for a complete list of exlusion criteria - INR 22 - Unable or unwilling to comply with study procedures - Permanent AF accepted by the patient and physician - Presence of severe mitral regurgitation or stenosis or history of valvular surgery - AF with a generally reversible cause (cardiac surgery, pulmonary embolism, hyperthyroidism) - Chronic inflammatory disease or evidence of active infection (as evidenced by increased white blood cell count, elevated CRP level or fever > 38,5 °C) - NYHA class IV heart failure symptoms or left ventricular ejection fraction

Design outcomes

Primary

MeasureTime frame
Main study parameters are the changes of biomarkerlevels overtime during the follow-up period. These will be associated with the incidence of recurrent AF after 6-8 months follow-up.

Secondary

MeasureTime frame
Additional study parameters on the process of atrial remodeling and clinical data will be collected and include: - 2 echocardiographies during the follow-up visits as a non-invasive marker of atrial mechanical or structural remodeling - clinical data on cardiac history - in depth ECG analysis

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)