Clinical trial NCT06481137: Reversibility of Cardiac Conduction Disturbances Following TAVI
Official title: InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Transcatheter Aortic Valve Implantation
Conduction Disturbances
Keywords: Aortic stenosis
Transcatheter Aortic Valve Implantation
Conduction Disturbances
Lead sponsor: Institut d'Investigació Biomèdica de Bellvitge
Sponsor class: OTHER
Collaborators: name: Hospital Universitari de Bellvitge
name: Hospital Universitario La Paz
name: Hospital Vall d'Hebron
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario A Coruna Spain
name: Hospital Clinico Universitario de Santiago
name: Hospital Universitario Central de Asturias
name: Hospital Universitario Marqués de Valdecilla
name: Hospital Clínico Universitario de Valladolid
First posted: 2024-07-01
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


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.

Primary outcomes:
measure: Incidence of retrogradation
timeFrame: 30 days
measure: Need for cardiac pacing (incidence of advanced atrioventricular block)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: L' Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
References: