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Search / Trial NCT03488420

Canadian EdoxAban(Lixiana®) Registry in Patients With ATrial Fibrillation/Flutter With Confirmed ValvUlar HeaRt DiseasE

Launched by MONTREAL HEART INSTITUTE · Mar 28, 2018

Trial Information

Current as of May 27, 2025

Completed

Keywords

ClinConnect Summary

This is an observational, prospective, multicenter, edoxaban Canadian registry of adults (≥18) diagnosed or confirmed with AF and/or AFL with VHD, within the last 12 months, according to local standard procedures and judged by the investigator to be at risk of stroke and in whom anticoagulation with NOAC is clinically indicated and who are prescribed edoxaban. A total of about 300 patients will be enrolled from approximately 10 sites in Quebec. Patients will be treated according to standard local practices. There is no formal interventions. Treatment decisions are left to the physician's di...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Male and female patients aged ≥ 18 years at baseline (signing of consent);
  • 2. Willing and able to provide written informed consent;
  • 3. Patient diagnosed or confirmed with AF and/or AFL within the last 12 months of signed consent form;
  • 4. Patient with VHD confirmed by echocardiography within the last 36 months of signed consent form except for mitral stenosis that must be confirmed within the last 12 months;
  • 5. Patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban.
  • Exclusion Criteria:
  • 1. Patients with AF and/or AFL secondary to reversible cause;
  • 2. Patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis;
  • 3. Patients planned to have an intervention for valvular heart disease in the next 12 months;
  • 4. Pregnant or breastfeeding women.
  • 5. Short term anticoagulation post cardioversion or ablation.

About Montreal Heart Institute

The Montreal Heart Institute (MHI) is a leading academic research center dedicated to advancing the field of cardiology through innovative clinical trials and groundbreaking medical research. Renowned for its commitment to improving patient care, MHI integrates clinical practice with cutting-edge research, fostering collaboration among healthcare professionals, scientists, and industry partners. The institute focuses on a wide range of cardiovascular conditions, aiming to develop and evaluate new therapies and interventions that enhance outcomes for patients with heart disease. With a strong emphasis on ethical standards and patient safety, the Montreal Heart Institute is at the forefront of cardiovascular research, contributing significantly to the global advancement of heart health.

Locations

Sherbrooke, Quebec, Canada

Montréal, Quebec, Canada

Granby, Quebec, Canada

Greenfield Park, Quebec, Canada

Laval, Quebec, Canada

Québec, Quebec, Canada

Rimouski, Quebec, Canada

Trois Rivières, Quebec, Canada

Saint Georges, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Katia Dyrda, MD

Principal Investigator

Montreal Heart Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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