Reversibility of Cardiac Conduction Disturbances Following TAVI (TAVI-REVERSE)

Institut d'Investigació Biomèdica de Bellvitge

Status: Enrolling

Conditions: Conduction Disturbances; Transcatheter Aortic Valve Implantation; Aortic Stenosis

Treatments: Diagnostic Test: ePatch (extended Holter Monitoring); Diagnostic Test: Electrophysiological study (EP study)

Study type: Interventional

Funder types: Other

Identifiers

NCT06481137

ICPS025/24

PI23/00310 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 209 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 2 patient groups

Positive initial (3-7 days following TAVI) electrophysiological study (EP+)

Experimental group

Description:

Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI.

Treatment:

Diagnostic Test: Electrophysiological study (EP study)

Diagnostic Test: ePatch (extended Holter Monitoring)

Negative initial (3-7 days following TAVI) electrophysiological study (EP-)

Other group

Description:

Continuous ECG monitoring during 4 weeks.

Treatment:

Diagnostic Test: ePatch (extended Holter Monitoring)