AzTrials
AzTrials

Aortic Valve DiseaseMARENCT02153307

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

A study testing Implantable loop recorders system Reveal ICM LINQ®, in people with Aortic Valve Disease and Conduction Disturbances, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Aortic Valve Disease, Conduction Disturbances
What is being tested?
Implantable loop recorders system Reveal ICM LINQ®,
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCanada
Study dates
Jan 2014to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting

  • IUCPQ

    Québec, Quebec, G1V 4G5

    Emilie Pelletier Beaumont, M.Sc., 418-656-8711 ext. 3929, Emilie.Pelletier-Beaumont@criucpq.ulaval.ca

    Recruiting

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Implantable loop recorders system Reveal ICM LINQ®,
Medical subject headings
Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable loop recorders system Reveal ICM LINQ®,Device

Study groups in NCT02153307
Study groupRoleWhat they receive
Implantable loop recorders Reveal ICM LINQ®,ExperimentalNot described
Receives: Device: Implantable loop recorders system Reveal ICM LINQ®,

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1Year

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

    Measured: 1 Year

Secondary outcomes (7)

  1. -Rate of high degree or complete of AVB

    Measured: Within the first month after TAVI procedure

  2. -Rate of high degree or complete of AVB

    Measured: 6-month follow-up

  3. -Rate of high degree or complete AVB

    Measured: 24-month follow-up

  4. -Rate of high degree or complete AVB

    Measured: 36-month follow-up

  5. -Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI

    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.

    Measured: Within the first 3 years following TAVI procedure

  6. -Rate of new atrial fibrillation or ventricular arrhythmias

    Measured: Within the first 3 years following TAVI procedure

  7. -Changes in left ventricular function and mitral regurgitation over time

    Measured: Within the first 3 years following TAVI procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMay 2020
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02153307
Sponsor's protocol ID
MARE
Acronym
MARE
Status last verified
Nov 2026
First submitted
26 May 2014
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20031657

  • 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.

    PubMed 313146

  • El-Khally Z, Thibault B, Staniloae C, Theroux P, Dubuc M, Roy D, Guerra P, Macle L, Talajic M. Prognostic significance of newly acquired bundle branch block after aortic valve replacement. Am J Cardiol. 2004 Oct 15;94(8):1008-11. doi: 10.1016/j.amjcard.2004.06.055.

    PubMed 15476613

  • Thomas JL, Dickstein RA, Parker FB Jr, Potts JL, Poirier RA, Fruehan CT, Eich RH. Prognostic significance of the development of left bundle conduction defects following aortic valve replacement. J Thorac Cardiovasc Surg. 1982 Sep;84(3):382-6.

    PubMed 7109669

  • Foppl M, Hoffmann A, Amann FW, Roth J, Stulz P, Hasse J, Gradel E, Burckhardt D. Sudden cardiac death after aortic valve surgery: incidence and concomitant factors. Clin Cardiol. 1989 Apr;12(4):202-7. doi: 10.1002/clc.4960120405.

    PubMed 2714032

  • van der Boon RM, Nuis RJ, Van Mieghem NM, Jordaens L, Rodes-Cabau J, van Domburg RT, Serruys PW, Anderson RH, de Jaegere PP. New conduction abnormalities after TAVI--frequency and causes. Nat Rev Cardiol. 2012 May 1;9(8):454-63. doi: 10.1038/nrcardio.2012.58.

    PubMed 22547171

  • Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18;57(3):253-69. doi: 10.1016/j.jacc.2010.12.005. Epub 2011 Jan 7.

    PubMed 21216553

  • Dou J, Xia L, Zhang Y, Shou G, Wei Q, Liu F, Crozier S. Mechanical analysis of congestive heart failure caused by bundle branch block based on an electromechanical canine heart model. Phys Med Biol. 2009 Jan 21;54(2):353-71. doi: 10.1088/0031-9155/54/2/012. Epub 2008 Dec 19.

    PubMed 19098354

  • Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, Garcia-Garcia H, Schultz C, van Domburg R, van Es GA, van Geuns R, de Jaegere P, Serruys PW. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation. EuroIntervention. 2010 Sep;6(4):475-84. doi: 10.4244/EIJ30V6I4A80.

    PubMed 20884435

  • Houthuizen P, Van Garsse LA, Poels TT, de Jaegere P, van der Boon RM, Swinkels BM, Ten Berg JM, van der Kley F, Schalij MJ, Baan J Jr, Cocchieri R, Brueren GR, van Straten AH, den Heijer P, Bentala M, van Ommen V, Kluin J, Stella PR, Prins MH, Maessen JG, Prinzen FW. Left bundle-branch block induced by transcatheter aortic valve implantation increases risk of death. Circulation. 2012 Aug 7;126(6):720-8. doi: 10.1161/CIRCULATIONAHA.112.101055. Epub 2012 Jul 12.

    PubMed 22791865

  • Testa L, Latib A, De Marco F, De Carlo M, Agnifili M, Latini RA, Petronio AS, Ettori F, Poli A, De Servi S, Ramondo A, Napodano M, Klugmann S, Ussia GP, Tamburino C, Brambilla N, Colombo A, Bedogni F. Clinical impact of persistent left bundle-branch block after transcatheter aortic valve implantation with CoreValve Revalving System. Circulation. 2013 Mar 26;127(12):1300-7. doi: 10.1161/CIRCULATIONAHA.112.001099. Epub 2013 Feb 26.

    PubMed 23443735

  • Urena M, Mok M, Serra V, Dumont E, Nombela-Franco L, DeLarochelliere R, Doyle D, Igual A, Larose E, Amat-Santos I, Cote M, Cuellar H, Pibarot P, de Jaegere P, Philippon F, Garcia del Blanco B, Rodes-Cabau J. Predictive factors and long-term clinical consequences of persistent left bundle branch block following transcatheter aortic valve implantation with a balloon-expandable valve. J Am Coll Cardiol. 2012 Oct 30;60(18):1743-52. doi: 10.1016/j.jacc.2012.07.035. Epub 2012 Oct 3.

    PubMed 23040577

  • Moya A, Garcia-Civera R, Croci F, Menozzi C, Brugada J, Ammirati F, Del Rosso A, Bellver-Navarro A, Garcia-Sacristan J, Bortnik M, Mont L, Ruiz-Granell R, Navarro X; Bradycardia detection in Bundle Branch Block (B4) study. Diagnosis, management, and outcomes of patients with syncope and bundle branch block. Eur Heart J. 2011 Jun;32(12):1535-41. doi: 10.1093/eurheartj/ehr071. Epub 2011 Mar 28.

    PubMed 21444367

  • Krahn AD, Klein GJ, Yee R, Takle-Newhouse T, Norris C. Use of an extended monitoring strategy in patients with problematic syncope. Reveal Investigators. Circulation. 1999 Jan 26;99(3):406-10. doi: 10.1161/01.cir.99.3.406.

    PubMed 9918528

  • Lombardi F, Calosso E, Mascioli G, Marangoni E, Donato A, Rossi S, Pala M, Foti F, Lunati M. Utility of implantable loop recorder (Reveal Plus) in the diagnosis of unexplained syncope. Europace. 2005 Jan;7(1):19-24. doi: 10.1016/j.eupc.2004.09.003.

    PubMed 15670962

Questions about this trial

What is this clinical trial studying?

A study testing Implantable loop recorders system Reveal ICM LINQ®, in people with Aortic Valve Disease and Conduction Disturbances, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

-Rate and time of onset of high degree or complete AVB (time frame: 1Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153307, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in