Ambulatory Electrocardiographic Monitoring for the Detect... | NCT02153307

Studies
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

NCT02153307

Sponsor

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

Status

Recruiting

Last Update Posted

Mar 24, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Aortic Valve Disease
Conduction Disturbances

Interventions

Implantable loop recorders system Reveal ICM LINQ®,

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

May 2020Actual

Completion Date

Jul 2026Estimated

First Submitted Date

May 26, 2014

First Submission Date that Met QC Criteria

May 29, 2014

First Posted Date

Jun 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2026

Last Update Posted Date

Mar 24, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implantable loop recorders Reveal ICM LINQ®,	Experimental		Device: Implantable loop recorders system Reveal ICM LINQ®,

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantable loop recorders system Reveal ICM LINQ®,	Device		Implantable loop recorders Reveal ICM LINQ®,

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
-Rate and time of onset of high degree or complete AVB		1Year
-Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event		1 Year

Secondary Outcomes

Measure	Description	Time Frame
-Rate of high degree or complete of AVB		Within the first month after TAVI procedure
-Rate of high degree or complete of AVB		6-month follow-up
-Rate of high degree or complete AVB

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Josep Rodes, MD	Fondation IUCPQ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IUCPQ	Recruiting	Québec	Quebec	G1V 4G5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20031657	Background	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.
313146	Background	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.

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases