Objective
The objective of this study is to compare the outcomes of 2 groups who develop conduction abnormalities following TAVI. One group will undergo an electrophysiology study and potential pacemaker implantation prior to discharge. The second group will undergo 30-day cardiac monitoring to assess the stats of these conduction abnormalities. Based on the data collected and comparison of the 2 groups, the objective is to determine a definitive strategy for patients who develop conduction abnormalities following TAVI going forward.
Background
Conduction abnormalities can arise following TAVI, one of them being left bundle branch block. Some previous studies have shown that this can lead to further conduction issues, necessitating a pacemaker to take over the conduction of the heart rhythm. Other studies have shown that many of these conduction abnormalities resolve spontaneously after the heart has had a chance to heal, thus making the pacemaker unnecessary. A study is needed to determine which strategy is best.
Study Outcomes
Primary
- Composite variable that incorporates:
- Sudden cardiac death
- Syncope
- Atrioventricular conduction disorder requiring a pacemaker
- Acute and chronic pacemaker or EP study life-threatening complications during the follow-up period
Secondary
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- Age ≥18 years
- Informed consent to participate
- Persistent new-onset LBBB after TAVI implantation (i.e. present at day 1)
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 taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.