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NCT Number: NCT02559011

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bern University Hospital, Dep. of Cardiology

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with incidence of new onset atrial fibrillation and complete AVB within 12 months after TAVI

    Time frame: up to 12 months

Secondary outcomes

  1. Number of patients with resolution of atrial Fibrillation

    Time frame: up to 12 months

  2. Number of patients with resolution of Atrium Ventricular Block (AVB) after TAVI with permanent pacemaker (PPM) implantation

    Time frame: up to 12 months

  3. Number of patients with cardiac death due to arrhythmias

    Time frame: up to 12 months

  4. Number of patients with stroke

    Time frame: up to 12 months

  5. Number of patients with presyncope and syncope

    Time frame: up to 12 months

  6. Number of patients with pacemaker Implantation

    Time frame: up to 12 months

  7. Number of patients with cardiovascular mortality

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: Reveal

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2015
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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