Reversibility of Cardiac Conduction Disturbances Following TAVI
- Conditions
- Transcatheter Aortic Valve ImplantationAortic StenosisConduction Disturbances
- Interventions
- Diagnostic Test: Electrophysiological study (EP study)Diagnostic Test: ePatch (extended Holter Monitoring)
- Registration Number
- NCT06481137
- Lead Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 209
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive initial (3-7 days following TAVI) electrophysiological study (EP+) Electrophysiological study (EP study) Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI. Negative initial (3-7 days following TAVI) electrophysiological study (EP-) ePatch (extended Holter Monitoring) Continuous ECG monitoring during 4 weeks. Positive initial (3-7 days following TAVI) electrophysiological study (EP+) ePatch (extended Holter Monitoring) Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI.
- Primary Outcome Measures
Name Time Method Need for cardiac pacing (incidence of advanced atrioventricular block) 30 days 2. Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block).
Incidence of retrogradation 30 days 1. Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Universitari de Bellvitge
🇪🇸L' Hospitalet De Llobregat, Barcelona, Spain