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

Recruiting now · Not applicable

Conditions studied: Left Bundle-Branch Block, Aortic Valve Stenosis

In brief

The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).

Key facts

Study ID

NCT03303612

Run by

Montreal Heart Institute

People needed

250

Starts

2017-10-15

Expected to finish

2026-12-01

Last updated by the study team

2025-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Informed consent to participate
• Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)

You may not qualify if…

• 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

Where it is running

• Mazankowski Alberta Heart Institute — Edmonton, Alberta, Canada (enrolling)
• CIUSSS du Nord de l'Île de Mtl — Montreal, Quebec, Canada (enrolling)
• Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada, Canada (enrolling)
• QEII Health Sciences Center — Halifax, Nova Scotia, Canada (enrolling)
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada (enrolling)
• London Health Sciences Center (LHSC) — London, Ontario, Canada (enrolling)
• University of Ottawa Heart Institute (UOHI) — Ottawa, Ontario, Canada (enrolling)
• Montreal Heart Institute — Montreal, Quebec, Canada (enrolling)
• New Brunswick Heart Center — Saint John, New Brunswick, Canada
• Centre Hospitalier Universitaire de Nantes — Nantes, Cedex 01, France

Full record on ClinicalTrials.gov

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