NCT06481137

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 209 (estimated)
• Sponsor: Institut d'Investigació Biomèdica de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis
• Transcatheter Aortic Valve Implantation
• Conduction Disturbances

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-17
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

1 site across 1 country: Spain