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RECRUITINGINTERVENTIONAL

Reversibility of Cardiac Conduction Disturbances Following TAVI

InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIAGNOSTIC_TEST

Electrophysiological study (EP study)

Electrophysiological study: A second EP study 30-45 days after TAVI will be performed in the group of patients with positive EP study 3-7 days after TAVI.

DIAGNOSTIC_TEST

ePatch (extended Holter Monitoring)

Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI

Locations (1)

Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain