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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Sponsor:
Information provided by (Responsible Party):
Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier:
NCT02153307
First received: May 26, 2014
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Aortic Valve Disease
Conduction Disturbances
Device: Implantable loop recorders system Reveal ICM LINQ®,
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Further study details as provided by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:

Primary Outcome Measures:
  • -Rate and time of onset of high degree or complete AVB [ Time Frame: 1Year ] [ Designated as safety issue: Yes ]
  • -Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • -Rate of high degree or complete of AVB [ Time Frame: Within the first month after TAVI procedure ] [ Designated as safety issue: Yes ]
  • -Rate of high degree or complete of AVB [ Time Frame: 6-month follow-up ] [ Designated as safety issue: Yes ]
  • -Rate of high degree or complete AVB [ Time Frame: 24-month follow-up ] [ Designated as safety issue: Yes ]
  • -Rate of high degree or complete AVB [ Time Frame: 36-month follow-up ] [ Designated as safety issue: Yes ]
  • -Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI [ Time Frame: Within the first 3 years following TAVI procedure ] [ Designated as safety issue: Yes ]
    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.

  • -Rate of new atrial fibrillation or ventricular arrhythmias [ Time Frame: Within the first 3 years following TAVI procedure ] [ Designated as safety issue: Yes ]
  • -Changes in left ventricular function and mitral regurgitation over time [ Time Frame: Within the first 3 years following TAVI procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: January 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implantable loop recorders Reveal ICM LINQ®, Device: Implantable loop recorders system Reveal ICM LINQ®,

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02153307

Locations
Canada
IUCPQ Recruiting
Quebec, Canada, G1V 4G5
Contact: Emilie Pelletier Beaumont, M.Sc.    418-656-8711 ext 3929    Emilie.Pelletier-Beaumont@criucpq.ulaval.ca   
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Investigators
Principal Investigator: Josep Rodes, MD IUCPQ
  More Information

Publications:
Surawicz B, Childers R, Deal BJ, Gettes LS, Bailey JJ, Gorgels A, Hancock EW, Josephson M, Kligfield P, Kors JA, Macfarlane P, Mason JW, Mirvis DM, Okin P, Pahlm O, Rautaharju PM, van Herpen G, Wagner GS, Wellens H; American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; American College of Cardiology Foundation; Heart Rhythm Society. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III: intraventricular conduction disturbances: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009 Mar 17;53(11):976-81. doi: 10.1016/j.jacc.2008.12.013. Review.

Responsible Party: Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT02153307     History of Changes
Other Study ID Numbers: MARE
Study First Received: May 26, 2014
Last Updated: May 29, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Bundle-Branch Block
Atrioventricular Block
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Block
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014