Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study

Aortic Valve Disease Clinical Trial

— MARE  

Official title:

Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02153307
• Other study ID #: MARE
• Status: Recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the incidence and predictors of high degree or complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve implantation (TAVI) and to evaluate the usefulness of the Reveal LINQ® insertable Cardiac Monitor (ICM) (Medtronic, Inc., Minneapolis, USA) for the detection of significant arrhythmias in patients with NOP-LBBB following TAVI.

Description:

This is a prospective observational study including patients undergoing TAVI with either self- or balloon-expandable valves. After the procedure, patients will be on ECG monitoring during the hospitalization period (or at least 72 hours), and an ECG will be performed daily until hospital discharge in all patients. Patients with new-onset persistent LBBB at hospital discharge (new-onset LBBB of a duration of at least 48 h which persists at hospital discharge, at least 3 days and up to 15 days after the procedure) will receive an implantable loop recorder Reveal ICM LINQ®, which will be implanted subcutaneously to record adequate QRS complexes and P waves. The patients will be followed in outpatient clinic visits at 1, 12, 24 and 36 months after TAVR, or if symptoms suggestive of cardiac origin or relevant arrhythmic events occur. The device will be manually interrogated in each visit. Phone contacts will be also carried out every three months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2024
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Patients undergoing TAVI with either balloon or self-expandable valves who develop new-onset LBBB persistent at hospital discharge, at least 3 days after the procedure

Exclusion Criteria:

• Failure to provide informed consent

• Baseline pacemaker/defibrillator or pacemaker/defibrillator implanted during the hospitalization period following the TAVI procedure

• Pre-existing complete LBBB

• Patients with a life-expectancy of less than 2 years

Related Conditions & MeSH terms

• Aortic Valve Disease
• Atrioventricular Block
• Bundle-Branch Block
• Conduction Disturbances

Intervention

Device:
• Implantable loop recorders system Reveal ICM LINQ®,

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1. — View Citation

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Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18;57(3):253-69. doi: 10.1016/j.jacc.2010.12.005. Epub 2011 Jan 7. — View Citation

Lombardi F, Calosso E, Mascioli G, Marangoni E, Donato A, Rossi S, Pala M, Foti F, Lunati M. Utility of implantable loop recorder (Reveal Plus) in the diagnosis of unexplained syncope. Europace. 2005 Jan;7(1):19-24. doi: 10.1016/j.eupc.2004.09.003. — View Citation

Moya A, Garcia-Civera R, Croci F, Menozzi C, Brugada J, Ammirati F, Del Rosso A, Bellver-Navarro A, Garcia-Sacristan J, Bortnik M, Mont L, Ruiz-Granell R, Navarro X; Bradycardia detection in Bundle Branch Block (B4) study. Diagnosis, management, and outcomes of patients with syncope and bundle branch block. Eur Heart J. 2011 Jun;32(12):1535-41. doi: 10.1093/eurheartj/ehr071. Epub 2011 Mar 28. — View Citation

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Task Force members; Brignole M, Vardas P, Hoffman E, Huikuri H, Moya A, Ricci R, Sulke N, Wieling W; EHRA Scientific Documents Committee; Auricchio A, Lip GY, Almendral J, Kirchhof P, Aliot E, Gasparini M, Braunschweig F; Document Reviewers; Lip GY, Almendral J, Kirchhof P, Botto GL; EHRA Scientific Documents Committee. Indications for the use of diagnostic implantable and external ECG loop recorders. Europace. 2009 May;11(5):671-87. doi: 10.1093/europace/eup097. No abstract available. Erratum In: Europace. 2009 Jun;11(6):836. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-Rate and time of onset of high degree or complete AVB		1Year
Primary	-Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event		1 Year
Secondary	-Rate of high degree or complete of AVB		Within the first month after TAVI procedure
Secondary	-Rate of high degree or complete of AVB		6-month follow-up
Secondary	-Rate of high degree or complete AVB		24-month follow-up
Secondary	-Rate of high degree or complete AVB		36-month follow-up
Secondary	-Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI	Periprocedural results of TAVI of patients with NOP-LVV will be used to characterize predictors of high degree or complete AVB. Moreover, electrocardiographic characteristics at hospital discharge of patients with NOP-LVV will also be used to characterize predictors of high degree or complete AVB.	Within the first 3 years following TAVI procedure
Secondary	-Rate of new atrial fibrillation or ventricular arrhythmias		Within the first 3 years following TAVI procedure
Secondary	-Changes in left ventricular function and mitral regurgitation over time		Within the first 3 years following TAVI procedure