Reduction of AF ablation Induced Thrombo-Embolic Incidence Pilot Study - REDUCE-TE Pilot Study

Biotronik SE & Co. KG0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* sympotomatic paroxysmal atrial fibrillation (AF)
•* indication for left atrial ablation for AF according to ESC guidelines
•* Anticoagulation according to clinical routine using coumarin derivates with a target INR between 2.0 and 3.0 for at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
•* geographically stable during the study
•* patient is willing and able to provide written informed consent

•* < 18 years
•* Long standing persistent or persistent Atrial Fibrillation
•* CHA2DS2-VASc score >= 5
•* Prior ischemic stroke or Transient Ischemic Attack
•* Previous PV ablation
•* Contraindication for antigoagulation therapy
•* Contraindication for Diffusion-Weighted MRI
•* Claustrophobia
•* Contraindication for transesophageal echocardiography (TEE) or intracardiac echography (ICE, if TEE not possible)
•* Implanted cardiovascular device
•* Acute coronary syndrome < 3 months prior to scheduled ablation
•* Moderate to severe valvular heart disease
•* LA size > 55 mm
•* non-controlled heart failure or current and recent heart failure (< 1 month prior to ablation)
•* Ejection fraction < 35%
•* Conditions that prevent patient*s participation in neurocognitive assessment
•* Female patients who are pregnant or breast feeding
•* footnote: ferromagnetic implants without approval for MRI investigations at the respective MRI unit.

发起方