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

NCT02559011 | Completed

• 1 other identifier: 2015_09_21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

Arrhythmias, Cardiac; Transcatheter Aortic Valve implantation; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

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

  up to 12 months

Secondary Outcomes (7)

• 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

Study Arms (1)

All study participants

Patients who need a TAVI with symptomatic severe aortic valve stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Severe symptomatic aortic valve stenosis undergoing TAVI

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital, Dep. of Cardiology

Bern, 3010, Switzerland

Location

Related Publications (13)

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  PMID: 687491 BACKGROUND

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  PMID: 25466975 BACKGROUND

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  PMID: 5020795 BACKGROUND

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  PMID: 21138915 BACKGROUND

• Moreno R, Dobarro D, Lopez de Sa E, Prieto M, Morales C, Calvo Orbe L, Moreno-Gomez I, Filgueiras D, Sanchez-Recalde A, Galeote G, Jimenez-Valero S, Lopez-Sendon JL. Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. Circulation. 2009 Aug 4;120(5):e29-30. doi: 10.1161/CIRCULATIONAHA.109.849281. No abstract available.

  PMID: 19652115 BACKGROUND

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  PMID: 22547171 BACKGROUND

• Houthuizen P, Van Garsse LA, Poels TT, de Jaegere P, van der Boon RM, Swinkels BM, Ten Berg JM, van der Kley F, Schalij MJ, Baan J Jr, Cocchieri R, Brueren GR, van Straten AH, den Heijer P, Bentala M, van Ommen V, Kluin J, Stella PR, Prins MH, Maessen JG, Prinzen FW. Left bundle-branch block induced by transcatheter aortic valve implantation increases risk of death. Circulation. 2012 Aug 7;126(6):720-8. doi: 10.1161/CIRCULATIONAHA.112.101055. Epub 2012 Jul 12.

  PMID: 22791865 BACKGROUND

• Nozica N, Siontis GCM, Elchinova EG, Goulouti E, Asami M, Bartkowiak J, Baldinger S, Servatius H, Seiler J, Tanner H, Noti F, Haeberlin A, Branca M, Lanz J, Stortecky S, Pilgrim T, Windecker S, Reichlin T, Praz F, Roten L. Assessment of New Onset Arrhythmias After Transcatheter Aortic Valve Implantation Using an Implantable Cardiac Monitor. Front Cardiovasc Med. 2022 May 16;9:876546. doi: 10.3389/fcvm.2022.876546. eCollection 2022.

  PMID: 35651903 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephan Windecker, Prof. Dr. med.

  Bern University Hospital, Dep. of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 24, 2015
• Study Start: March 1, 2016
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

CH (1)