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
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Contact Information
Primary
Guillem Muntané Carol, MD, PhD
gmuntanec@bellvitgehospital.cat
+342607500
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 209
Treatments
Experimental: Positive initial (3-7 days following TAVI) electrophysiological study (EP+)
Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI.
Other: Negative initial (3-7 days following TAVI) electrophysiological study (EP-)
Continuous ECG monitoring during 4 weeks.
Sponsors
Leads: Institut d'Investigació Biomèdica de Bellvitge
Collaborators: Hospital Vall d'Hebron, Hospital Clinico Universitario de Santiago, Hospital Universitario La Paz, Hospital Universitario Marqués de Valdecilla, Hospital Universitari de Bellvitge, Hospital Universitario Ramon y Cajal, Hospital Clínico Universitario de Valladolid, Hospital Universitario Central de Asturias, Hospital Universitario A Coruna Spain

This content was sourced from clinicaltrials.gov