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

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ClinicalTrials.gov Identifier: NCT02559011
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

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.


Condition or disease
Aortic Valve Stenosis

Detailed 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 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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
Study Start Date : March 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
All study participants
Patients who need a TAVI with symptomatic severe aortic valve stenosis



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with severe, symptomatic aortic valve 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559011


Contacts
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Contact: Anja Thoms +41 31 632 30 70 Anja.Thoms@insel.ch

Locations
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Switzerland
Bern University Hospital, Dep. of Cardiology Recruiting
Bern, Switzerland, 3010
Contact: Stephan Windecker, Prof. Dr. med.    +41 31 632 96 53    Stephan.Windecker@insel.ch   
Contact: Fabien Praz, Dr. med.    +41 31 632 21 11    Fabien.Praz@insel.ch   
Principal Investigator: Stephan Windecker, Prof. Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Stephan Windecker, Prof. Dr. med. Bern University Hospital, Dep. of Cardiology

Publications:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02559011     History of Changes
Other Study ID Numbers: 2015_09_21
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

Keywords provided by University Hospital Inselspital, Berne:
Arrhythmias, Cardiac
Transcatheter Aortic Valve implantation
Aortic Valve Stenosis

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction