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Implantable Loop Recorder

Implantable loop recorders system Reveal ICM LINQ®, for Aortic Valve Stenosis (MARE Trial)

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
-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
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

MARE Trial 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.

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.Check my eligibility
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.

MARE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I developed a new heart rhythm issue after a valve replacement via TAVI, still present 3 days later.

MARE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
-Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event
-Rate and time of onset of high degree or complete AVB
Secondary outcome measures
-Changes in left ventricular function and mitral regurgitation over time
-Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI
-Rate of high degree or complete AVB
+2 more

Awards & Highlights

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

MARE Trial Design

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

Find a Location

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
9,662 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate participation rate in this investigation?

"Affirmative. The clinical trial registry, clinicialtrials.gov, indicates that recruitment for this study is ongoing and has been since it was initially posted on January 1st 2014. 80 patients are needed to be recruited from a single medical centre."

Answered by AI

Is this clinical research actively recruiting participants?

"The clinical trial in question is actively seeking participants, having been uploaded to clinicaltrials.gov on January 1st 2014 and last edited September 20th 2021."

Answered by AI
Recent research and studies
~7 spots leftby Feb 2025