Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontreal Heart Institute
About this trial
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
Qualifiers
Age ≥18 years
Informed consent to participate
Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pacemaker implant
- Transcutaneous cardiac monitor
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov