Risk Profile for Patients With Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01510210|
Recruitment Status : Active, not recruiting
First Posted : January 16, 2012
Last Update Posted : May 11, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||Identification of a Risk Profile to Guide Atrial Fibrillation Therapy|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2018|
- Success of rhythm control [ Time Frame: 12 month ](1) < 1 second AF on end-of-study ECG; (2) < 30 seconds AF on end-of-study 48-hour Holter recording; (3) no AF on end-of-study 2 weeks Vitaphone ECG-card recording.
- Time to recurrence of (a)symptomatic AF [ Time Frame: 1+3+6+9+12 month ]by assessment Percentage AF-burden on 24-holter during follow up
- Failure of rhythm control, i.e. permanent AF [ Time Frame: 1+3+6+9+12 month ]failure of rhythm control medication or electric cardioversion.
- Risk profiles associated with early versus late AF recurrence [ Time Frame: 1month and 12 month ]These parameters include underlying (heart) disease and risk factors (including age, family history for AF, signs of ischemia, coronary risk factors, pulmonary disease, diabetes, obesity, sleep apnea, esophageal problems), lifestyle (including caffeine and alcohol intake, exercise), autonomic trigger patterns of AF (i.e. vagal or adrenergic induced AF, or combination
- Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF [ Time Frame: 1+3+6+9+12 month ]clinical commplaints and 3-lead Holter monitoring will be used for assessing the onset of AF episode
- Changes in atrial and ventricular echocardiographic parameters [ Time Frame: 1month and 12 month ]Echocardiographic measures of LA size (LA size parasternal long axis view, LA volume,LA ejection fraction measurement, electro-echocardiographic parameters (Tissue Doppler total atrial conduction time (during sinus rhythm), AF cycle length and velocity (during AF)), and parameters of diastolic dysfunction, including E (early mitral valve flow velocity), A (late mitral valve flow velocity), E/A ratio, deceleration time, E' (early tissue Doppler lengthening velocity), and E/E' ratio
- Cardiovascular morbidity and mortality [ Time Frame: 1month and 12month ]hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.
- Pulmonary vein ablation [ Time Frame: 1month, 3month, 6month, 9 month, 12month ]hospital admission for pulmonary vein ablation will be monitoring during the study.
- Pathophysiological mechanisms associated with AF and success of rhythm control [ Time Frame: baseline-12 months ]To study pathophysiological mechanisms of AF, e.g. collagen mediated or inflammation mediated AF
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510210
|University Medical Center Groningen|
|Groningen, Netherlands, 9713 GZ Groningen|
|Principal Investigator:||Harry Crijns, MD PhD||Maastricht University Medical Center|
|Principal Investigator:||Isabelle C Van Gelder, MD PhD||University Medical Center Groningen|