Study 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.
Eligible Conditions
- Aortic Valve Stenosis
- Heart Block
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: Within the first 3 years following TAVI procedure
1 Year
-Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event
1Year
-Rate and time of onset of high degree or complete AVB
36-month follow-up
-Rate of high degree or complete AVB
6-month follow-up
Heart rate
Year 3
-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 new atrial fibrillation or ventricular arrhythmias
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Implantable loop recorders Reveal ICM LINQ®,
1 of 1
Experimental Treatment
80 Total Participants · 1 Treatment Group
Primary Treatment: Implantable loop recorders system Reveal ICM LINQ®, · No Placebo Group · N/A
Implantable loop recorders Reveal ICM LINQ®,
Device
Experimental Group · 1 Intervention: Implantable loop recorders system Reveal ICM LINQ®, · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within the first 3 years following tavi procedure
Who is running the clinical trial?
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecLead Sponsor
35 Previous Clinical Trials
9,442 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
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- 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.
- Task Force members; Brignole M, Vardas P, Hoffman E, Huikuri H, Moya A, Ricci R, Sulke N, Wieling W; EHRA Scientific Documents Committee; Auricchio A, Lip GY, Almendral J, Kirchhof P, Aliot E, Gasparini M, Braunschweig F; Document Reviewers; Lip GY, Almendral J, Kirchhof P, Botto GL; EHRA Scientific Documents Committee. Indications for the use of diagnostic implantable and external ECG loop recorders. Europace. 2009 May;11(5):671-87. doi: 10.1093/europace/eup097. No abstract available. Erratum In: Europace. 2009 Jun;11(6):836.
- Josep Rodes-Cabau 2014. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02153307.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
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