Health TrialsbyHealthPanel

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

ConditionsAortic Valve DiseaseConduction Disturbances
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Implantable loop recorders system Reveal ICM LINQ®,

    Device

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Implantable loop recorders Reveal ICM LINQ®,Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

-Rate and time of onset of high degree or complete AVB

Time frame
1Year
2

-Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event

Time frame
1 Year

Secondary outcomes

1

-Rate of high degree or complete of AVB

Time frame
Within the first month after TAVI procedure
2

-Rate of high degree or complete of AVB

Time frame
6-month follow-up
3

-Rate of high degree or complete AVB

Time frame
24-month follow-up
4

-Rate of high degree or complete AVB

Time frame
36-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Lead sponsor

Source ClinicalTrials.gov
Apply now