Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
Transcatheter aortic valve implantation (TAVI) has emerged as a valuable minimal-invasive
 treatment option in patients with symptomatic severe aortic valve (AV) stenosis at
 prohibitive or increased risk for conventional open-heart surgery. Recent randomized clinical
 trials reported a large treatment effect of TAVI over medical treatment among inoperable
 patients and similar or superior outcomes compared with surgical aortic valve replacement in
 high to intermediate risk patients. However, atrio-ventricular conduction disturbances and
 arrhythmias (in particular atrial fibrillation) before, during or after TAVI remain a matter
 of concern as they have important consequences.

 The objective of this study is 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).

 One hundred patients will be enrolled in this 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 present study will provide information about the actual incidence and impact of
 symptomatic and silent arrhythmias and AV-conduction disturbances among patients with severe,
 symptomatic aortic stenosis undergoing TAVI. Specifically, the study estimate the burden of
 arrhythmias before TAVI and to accurately determine the incidence of new onset atrial
 fibrillation and complete AV-block within 12 months after the procedure. Identifying patients
 at risk for AV- conduction abnormalities, atrial fibrillation (AF), and non-sustained or
 sustained ventricular arrhythmias may guide future preventive measures, medical treatment and
 improve patients outcomes after TAVI.
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.
Inclusion Criteria:

 -  Severe symptomatic aortic valve stenosis undergoing TAVI

 Exclusion Criteria

 -  Missing IC

 -  Pacemaker, internal cardioverter-defibrillator or cardiac resynchronization therapy
 (CRT) device at the time of screening

 -  Anatomic or clinical contraindications for TAVI or REVEAL insertion

 -  Patient currently participating in another study evaluating a new transcatheter valve
 prosthesis or a new drug