Reversibility of Cardiac Conduction Disturbances Following TAVI

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances

In brief

The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block. In this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI. In this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.

Key facts

Study ID

NCT06481137

Run by

Institut d'Investigació Biomèdica de Bellvitge

People needed

209

Starts

2024-06-17

Expected to finish

2026-12-31

Last updated by the study team

2024-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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