Aortic Stenosis, Conduction Disturbances, Transcatheter Aortic Valve Implantation
Conditions
Keywords
Aortic stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances
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.
Interventions
DIAGNOSTIC_TESTElectrophysiological 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_TESTePatch (extended Holter Monitoring)
Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI
Sponsors
Hospital Universitari de Bellvitge
Hospital Universitario La Paz
Hospital Vall d'Hebron
Hospital Universitario Ramon y Cajal
Hospital Universitario A Coruna Spain
Hospital Clinico Universitario de Santiago
Hospital Universitario Central de Asturias
Hospital Universitario Marqués de Valdecilla
Hospital Clínico Universitario de Valladolid
Institut d'Investigació Biomèdica de Bellvitge
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
Spain
Contacts
Primary ContactGuillem Muntané Carol, MD, PhD
Outcome results
None listed