IUCPQ
Québec, Quebec, G1V 4G5, Canada
Location status: Recruiting
NCT Number: NCT02153307
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Québec, Quebec, G1V 4G5, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Time frame: 1Year
Time frame: 1 Year
Time frame: Within the first month after TAVI procedure
Time frame: 6-month follow-up
Time frame: 24-month follow-up
Time frame: 36-month follow-up
Time frame: Within the first 3 years following TAVI procedure
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.
Time frame: Within the first 3 years following TAVI procedure
Time frame: Within the first 3 years following TAVI procedure
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Other
Acronym: MARE
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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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