Comparison of a clinical monitoring strategy versus electrophysiology-guided algorithmic approach in patients with a new left bundle branch block after transcatheter aortic valve implantation (COME-TAVI)
COME-TAVI
Lead PI & Sponsor
Dr. Manlucu
Local PI
Dr. Manlucu
Research Staff
Keza Motlana
Objective
The purpose of this study is to evaluate the incidence, predictors, and clinical impact of new-onset conduction abnormalities after transcatheter aortic valve implantation (TAVI), and to clarify their association with subsequent atrioventricular block and permanent pacemaker implantation
Target Number of Patients
20
Currently Enrolled
1
Primary Outcomes
- The primary outcome will capture the major consequences ensuing both strategies in patients with newonset LBBB post TAVI and will consist of 1) sudden cardiac death, 2) syncope, 3) atrioventricular conduction disorder requiring a pacemaker (Class I or IIa) and 4) acute and chronic pacemaker or EP study life-threatening complications during the 12-month follow-up period
- Hospitalization (total and cardiovascular)
- Cost-effectiveness
- Death (all-cause and cardiovascular)
- All acute and chronic pacemaker or EP study complications
- Symptomatic bradycardia (including sinus bradycardia) requiring pacemaker implantation
- Total pacemaker implantation rate
Secondary Outcomes
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 guidlines
The purpose of this study is to compare two pacemaker placement strategies: a) standard righ ventricular pacing (control group); and b) left bundle branch pacing (LBBP) (experimental group). Typically, patients who have heart block become dependent on pacemakers (i.e. life saving-devices that allow the heart to pump in an organized manner) to deliver electrical signals. If a patient is completely dependent on these electrical signals, they are at a risk of developing a weakening of their heart muscle called pacing-induced cardiomyopathy which is often associated with the development of heart failure. This study, therefore is looking at left bundle branch pacing, which is a novel approach to placing a pacemaker that attempts to prevent the risk of pacing induced cardiomyopathy and prevent heart failure.