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

Overview

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.

Detailed 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.

Interventions

• Device Implantable loop recorders system Reveal ICM LINQ®,

Primary outcome measures

• -Rate and time of onset of high degree or complete AVB [Time frame: 1Year]
• -Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event [Time frame: 1 Year]

Secondary outcome measures (7)

• -Rate of high degree or complete of AVB [Time frame: Within the first month after TAVI procedure]
• -Rate of high degree or complete of AVB [Time frame: 6-month follow-up]
• -Rate of high degree or complete AVB [Time frame: 24-month follow-up]
• -Rate of high degree or complete AVB [Time frame: 36-month follow-up]
• -Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI [Time frame: Within the first 3 years following TAVI procedure]
• -Rate of new atrial fibrillation or ventricular arrhythmias [Time frame: Within the first 3 years following TAVI procedure]
• -Changes in left ventricular function and mitral regurgitation over time [Time frame: Within the first 3 years following TAVI procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Canada · 1 center

• IUCPQ — Québec

Publications

• Piazza N, de Jaegere P, Schultz C, Becker AE, Serruys PW, Anderson RH. Anatomy of the aortic valvar complex and its implications for transcatheter implantation of the aortic valve. Circ Cardiovasc Interv. 2008 Aug;1(1):74-81. doi: 10.1161/CIRCINTERVENTIONS.108.780858. PMID 20031657
• Thompson R, Mitchell A, Ahmed M, Towers M, Yacoub M. Conduction defects in aortic valve disease. Am Heart J. 1979 Jul;98(1):3-10. doi: 10.1016/0002-8703(79)90313-2. No abstract available. PMID 313146
• El-Khally Z, Thibault B, Staniloae C, Theroux P, Dubuc M, Roy D, Guerra P, Macle L, Talajic M. Prognostic significance of newly acquired bundle branch block after aortic valve replacement. Am J Cardiol. 2004 Oct 15;94(8):1008-11. doi: 10.1016/j.amjcard.2004.06.055. PMID 15476613
• Thomas JL, Dickstein RA, Parker FB Jr, Potts JL, Poirier RA, Fruehan CT, Eich RH. Prognostic significance of the development of left bundle conduction defects following aortic valve replacement. J Thorac Cardiovasc Surg. 1982 Sep;84(3):382-6. PMID 7109669
• Foppl M, Hoffmann A, Amann FW, Roth J, Stulz P, Hasse J, Gradel E, Burckhardt D. Sudden cardiac death after aortic valve surgery: incidence and concomitant factors. Clin Cardiol. 1989 Apr;12(4):202-7. doi: 10.1002/clc.4960120405. PMID 2714032
• van der Boon RM, Nuis RJ, Van Mieghem NM, Jordaens L, Rodes-Cabau J, van Domburg RT, Serruys PW, Anderson RH, de Jaegere PP. New conduction abnormalities after TAVI--frequency and causes. Nat Rev Cardiol. 2012 May 1;9(8):454-63. doi: 10.1038/nrcardio.2012.58. PMID 22547171
• 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 Cardi PMID 21216553
• Dou J, Xia L, Zhang Y, Shou G, Wei Q, Liu F, Crozier S. Mechanical analysis of congestive heart failure caused by bundle branch block based on an electromechanical canine heart model. Phys Med Biol. 2009 Jan 21;54(2):353-71. doi: 10.1088/0031-9155/54/2/012. Epub 2008 Dec 19. PMID 19098354

Identifiers

NCT: NCT02153307 · MARE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗