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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Aortic Valve Stenosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All study participants<br>Patients who need a TAVI with symptomatic severe aortic valve stenosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with incidence of new onset atrial fibrillation and complete AVB within 12 months after TAVI |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with resolution of atrial Fibrillation |  | up to 12 months | 
| Number of patients with resolution of Atrium Ventricular Block (AVB) after TAVI with permanent pacemaker (PPM) implantation |  | up to 12 months | 
| Number of patients with cardiac death due to arrhythmias |  | up to 12 months | 
| Number of patients with stroke |  | up to 12 months | 
| Number of patients with presyncope and syncope |  | up to 12 months | 
| Number of patients with pacemaker Implantation |  | up to 12 months | 
| Number of patients with cardiovascular mortality |  | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arrhythmias, Cardiac, Transcatheter Aortic Valve implantation, Aortic Valve Stenosis