Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes

NOAH-AFNET

Leitung: Prof. Dr. Michael Böhm

♥ Aktuelle Studien

NOAH-AFNET

Pacemaker or defibrillator implanted for any reason with feature of detection of AHRE, implanted at least 2 months prior to randomisation.
AHRE detection feature activated adequately according to “Suggestions for optimal programming of devices for adequate detection of AHRE” (refer to Appendix VIII).
AHRE (≥ 180 bpm atrial rate and ≥ 6 min duration) documented by the implanted device via its atrial lead and stored digitally. Any AHRE episode recorded after adequate setting of AHRE detection algorithms is potentially eligible, but AHRE episodes detected in the first 2 months after implantation of a new device involving placement or repositioning of atrial electrodes are not eligible. AHRE episodes recorded in the first two months after a simple “box change” operation, i.e. exchange of a pacemaker or defibrillator device without exchange or repositioning of atrial electrodes, are eligible.
Age ≥ 65 years.
In addition, at least one of the following cardiovascular conditions leading to a CHA2DS2VASc score of 2 or more:
- Age ≥ 75 years
- Heart failure (clinically overt or LVEF < 45%)
- Arterial hypertension
- Diabetes mellitus
- Prior stroke or transient ischemic attack (TIA)
- Vascular disease (peripheral, carotid/cerebral, or aortic plaques on transesophageal echocardiogram)

General exclusion criteria

Any disease that limits life expectancy to less than 1 year
Participation in another controlled clinical trial, either within the past two months or still ongoing
Previous participation in the present trial NOAH - AFNET 6
Drug abuse or clinically manifest alcohol abuse

Exclusion criteria related to a cardiac condition

Any history of overt AF or atrial flutter
Indication for oral anticoagulation (e.g. deep venous thrombosis)
Contraindication for oral anticoagulation in general
Contraindication for edoxaban as stated in the current SmPC
Indication for long-term antiplatelet therapy other than acetylsalicylic acid, especially dual antiplatelet therapy (DAPT) with acetylsalicylic acid and one of the following agents: clopidogrel, prasugrel, or ticagrelor. Patients with a transient requirement for DAPT (e.g. after receiving a stent) will be eligible when the need for DAPT is no longer present.
Acute coronary syndrome, coronary revascularisation (PCI or bypass surgery), or overt stroke within 30 days prior to randomisation

Exclusion criteria based on laboratory abnormalities