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Search / Trial NCT03303612

Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI

Launched by MONTREAL HEART INSTITUTE · Oct 5, 2017

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating two different ways to monitor patients who develop a specific heart condition called left bundle branch block (LBBB) after undergoing a procedure to replace their aortic valve, known as transcatheter aortic valve implantation (TAVI). The researchers want to find out if using an advanced heart monitoring technique—an electrophysiology-guided algorithm—can do a better job at preventing serious issues like fainting, hospital stays, and death compared to the usual monitoring approach, which lasts for 30 days after the procedure.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with a new case of LBBB after their TAVI procedure. However, individuals who already have certain heart devices, such as a pacemaker, or had prior heart block conditions before TAVI, will not be able to join. If you participate, you can expect to be closely monitored and receive care based on the study's findings, contributing valuable information that could help improve treatment for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥18 years
  • Informed consent to participate
  • Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
  • Exclusion Criteria:
  • Prior pacemaker or implantable cardioverter-defibrillator
  • Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)
  • Class I or IIA indication for PPM implantation according to management guidelines

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

Montreal, Quebec, Canada

Edmonton, Alberta, Canada

Hamilton, Ontario, Canada

Nantes, , France

Halifax, Nova Scotia, Canada

Montreal, Quebec, Canada

Saint John, New Brunswick, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Sherbrooke, Quebec, Canada, Canada

Montréal, Quebec, Canada

Nantes, , France

Sherbrooke, , Canada

Patients applied

0 patients applied

Trial Officials

Léna Rivard, MD, MSC

Principal Investigator

Montreal Heart Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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