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

Withdrawn

Conditions: arrhythmia
atrial fibrillation
10007521

Registration Number: NL-OMON42398

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 160

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

we refer to protocol p. 12-13 for a complete list of exlusion criteria
- INR < 2 and not on NOAC treatment in patients with an indication for OAC
- Signs of cardiogenic shock: systolic BP< 90mmHg, urine output <0.5ml/kg/h, respiratory rate >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 < 25%
- Multivessel coronary artery disease or recent (<3months) ischemic cardiac disease

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are the changes of biomarkerlevels overtime during the<br /><br>follow-up period. These will be associated with the incidence of recurrent AF<br /><br>after 6-8 months follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional study parameters on the process of atrial remodeling and clinical<br /><br>data will be collected and include:<br /><br>- 2 echocardiographies during the follow-up visits as a non-invasive marker of<br /><br>atrial mechanical or structural remodeling<br /><br>- clinical data on cardiac history<br /><br>- in depth ECG analysis</p><br>