An observational study in Atrial Fibrillation, sponsored by Insel Gruppe AG, University Hospital Bern. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-04.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
The aim of the study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients with non-valvular atrial fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left atrial closure).
A questionnaire is sent to the patients and if there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing/unclear information.
The study population consists of 500 patients with non-valvular atrial fibrillation (AF) who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a similar group of 500 patients with non-valvular AF treated with oral anticoagulation (OAC).
In order to compare the two groups and reducing the bias due to confounding variables, a propensity score matching will be performed.
Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.
Non-valvular atrial fibrillation is the most common arrhythmia with an estimated prevalence of 1-2% in the general population, increasing with age. Patients with AF are at increased risk of thromboembolism, in particular ischemic stroke.
LAAC seems at the actual knowledge to be a valid alternative to OAC. The objective of this study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.
A questionnaire is sent to the patients asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. If there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing information.
The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of 500 patients with non-valvular AF who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a propensity score matched patients group of 500 patients with non-valvular AF treated with OAC.
Covariates for matching will be age, gender, renal function, coronary artery disease and its status of revascularization, left-ventricular function, HAS-BLED and CHA2DS2-VASc-Score.
Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 1,000 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Questionnaire to patients with non-valvular atrial fibrillation on OAC or NOAC
Other: Questionnaire
Questionnaire to patient with non-valvular atrial fibrillation who underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich
Other: Questionnaire
A clinical sweep follow up will be performed in all patients of both groups and results will be analyzed. It will be in form of a standardized questionnaire and if necessary telephone interviews asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. For all events, the source documents will be gathered from general physicians, cardiologists, hospitals or registry offices. The questionnaire will be sent by mail to the patients. If information is missing or unclear, patients and if necessary their treating physician will be contacted by phone.
Number of intermedium-term clinical outcomes, including thromboembolic events and bleeding complications in patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.
Time frame: Clinical sweep follow up, the mean follow-up will be approximately 3 years
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern