Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device

Summary

Participation Requirements

Description

Background TAVI has emerged as a valuable minimal-invasive treatment option in patients with symptomatic severe aortic valve stenosis at prohibitive or increased risk for conventional open-heart surgery. AV conduction disturbances and arrhythmias before, during or after TAVI remain a matter of conce...

Background TAVI has emerged as a valuable minimal-invasive treatment option in patients with symptomatic severe aortic valve stenosis at prohibitive or increased risk for conventional open-heart surgery. AV conduction disturbances and arrhythmias before, during or after TAVI remain a matter of concern as they have consequences. Prior to TAVI the ICM will be inserted under the skin of the chest under local anesthesia. The device will be interrogated just prior to readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The incidence of symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and its impact on medical and device treatment as well as clinical outcomes analyzed. All patients with severe, symptomatic aortic stenosis undergoing TAVI at the institution irrespective selected bioprosthesis will be included in the study. Final decision on eligibility will be made by the local Heart Team. Objective To investigate the incidence, nature and prognostic significance of AV-conduction disturbances and arrhythmias among patients with severe, symptomatic aortic stenosis undergoing TAVI before, during and after the procedure using a small implantable cardiac monitoring system (ICM; Medtronic REVEAL LinQTM). The primary endpoint of the study is to establish the incidence of new onset atrial fibrillation and complete AV-block within 12 months after TAVI. Methods One hundred patients with severe, symptomatic aortic stenosis undergoing TAVI will be enrolled in this prospective, observational study. Prior to TAVI (at least 4 weeks), at the time of preprocedural hemodynamic and anatomical assessment, the ICM will be inserted under the skin of the chest under local anesthesia. The device will be interrogated just prior to readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The incidence of symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and its impact on medical and device treatment as well as clinical outcomes analyzed. The study is observational: the patients will not be assigned to a specific intervention. Patients consenting will be monitored using a specific device that has been approved for market release. The objective of the study is to use the information obtained with this monitoring device to assess the incidence, nature and prognostic significance of atrioventricular conduction disturbances and arrhythmias among patients with severe, symptomatic aortic stenosis undergoing Transcatheter Aortic Valve Implantation before, during and after the procedure. The objective of the study is not to investigate the performance of the monitoring device.

Tracking Information