NCT03303612 Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
| NCT ID | NCT03303612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montreal Heart Institute |
| Condition | Left Bundle-Branch Block |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2017-10-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2017-10-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Léna Rivard, MD, MSC
PRINCIPAL INVESTIGATOR
Montreal Heart Institute
Frequently Asked Questions
Who can join the NCT03303612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Left Bundle-Branch Block. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03303612 currently recruiting?
Yes, NCT03303612 is actively recruiting participants. Contact the research team at lena.rivard@umontreal.ca for enrollment information.
Where is the NCT03303612 trial being conducted?
This trial is being conducted at Edmonton, Canada, Saint John, Canada, Halifax, Canada, Hamilton, Canada and 6 additional locations.
Who is sponsoring the NCT03303612 clinical trial?
NCT03303612 is sponsored by Montreal Heart Institute. The principal investigator is Léna Rivard, MD, MSC at Montreal Heart Institute. The trial plans to enroll 250 participants.