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Implantable Loop Recorder

Implantable Loop Recorders for Heart Block (MARE Trial)

Quebec, Canada
N/A
Recruiting
Led By Josep Rodes, MD
Research Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first 3 years following tavi procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the incidence of high degree or complete AVB in patients with new-onset persistent left bundle branch block following TAVI, and will also assess the usefulness of the Reveal LINQ ICM for detecting significant arrhythmias in these patients.

See full description
Who is the study for?
This trial is for patients who have a new type of heart block called left bundle branch block (LBBB) after getting a valve replacement through TAVI. They must not already have LBBB, pacemakers or defibrillators before the study, and should expect to live at least two more years.
What is being tested?
The study tests if a small device called Reveal LINQ® can detect serious heart rhythm problems in patients with new LBBB after TAVI. It records the heart's activity continuously to find any dangerous blocks that could happen without warning.See study design
What are the potential side effects?
Inserting the Reveal LINQ® may cause discomfort, bleeding, or infection at the site where it's placed under the skin. There might also be risks related to allergic reactions to materials in the device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first 3 years following tavi procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first 3 years following tavi procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
-Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Implantable loop recorders Reveal ICM LINQ®,Experimental Treatment1 Intervention

Find a Location

Closest Location:IUCPQ· Quebec, Canada

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecLead Sponsor
36 Previous Clinical Trials
9,655 Total Patients Enrolled
5 Trials studying Aortic Valve Stenosis
765 Patients Enrolled for Aortic Valve Stenosis
Josep Rodes, MDPrincipal InvestigatorFondation IUCPQ
1 Previous Clinical Trials
222 Total Patients Enrolled
~7 spots leftby Jan 2026