Reversibility of Cardiac Conduction Disturbances Following TAVI

Launched by INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how heart conduction problems might change after a procedure called transcatheter aortic valve implantation (TAVI), which is used to treat a condition known as aortic stenosis. Specifically, the researchers want to understand how often these conduction issues, particularly new ones that appear after TAVI, improve over time. They will monitor patients who have developed these issues to see if they need a pacemaker and to track any significant heart-related events that might occur.

To take part in the trial, you must be an adult who has had TAVI and is experiencing new conduction problems, such as a specific type called left bundle branch block. If you qualify, you will undergo an electrophysiological study to assess your heart's electrical activity a few days after the procedure. Depending on the study results, you may receive a pacemaker and be monitored closely for about a month to check for any heart rhythm issues. This study aims to gather important information that could help doctors better manage heart conduction disturbances after TAVI.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patients with indication for electrophysiological (EP) study after TAVI implantation according to European Guidelines. Patients must have persistent electrocardiographic conduction disturbances (ECG-CDs) that are present from day 2 after TAVI implantation (≥ 48h post-procedure):
• • De novo LBBB with QRS complex \>150ms and/or PR interval ≥240ms.
• • QRS widening or post-procedural PR lengthening \> 20ms in patients with baseline ECG-CDs.
• Exclusion Criteria:
• • Patients with previous pacemaker or implantable defibrillator.
• • Patients with baseline complete right bundle branch block.
• • Patients in need of cardiac resynchronization or physiological stimulation following TAVI.
• • Valve-in-valve procedures.
• • TAVI procedures in patients with severe aortic insufficiency.
• • Inability to sign the informed consent form.