Cardiovascular Diseases, Severe Aortic Valve Stenosis
Conditions
Keywords
TAVI(Transcatheter Aortic Valve Implantation)
Brief summary
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.
Detailed description
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.
Interventions
BEHAVIORALStandard care
Patients discharged according to standard care
DEVICEPhysioMem PM 100 4G ambulatory monitoring system
Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All inclusion criteria must be met * Age ≥ 18 years and * Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and * Presence of at least one of the following conduction disorders and * Pre-procedural basal conduction disorder (e.g., right/left bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec. * De novo conduction disorder after TAVI (de novo bundle branch block) with QRS between 120-160 msec. * Clinical stability at 24 hours post-procedure and * Capacity to give informed consent.
Exclusion criteria
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of all-cause death and rehospitalization for any reason | 30 days | Proportion of patients with: * All cause of death * Rehospitalization for any reason |
| Clinically relevant arrhythmic event requiring a change in therapy | 30 days | Proportion of patients with clinically relevant arrhythmic event requiring a change in therapy, defined as the occurrence of any of the following: * Cardiac conduction disorders * Clinically relevant tachyarrhythmias |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | 30 days | Incidence of all-cause death |
| Unscheduled hospital readmission for any reason | 30 days | Incidence of unscheduled hospital readmission for any reason |
| Cardiovascular death | 30 days | Incidence of cardiovascular death |
| Hospital readmission due to cardiovascular cause | 30 days | Incidence of Hospital readmission due to cardiovascular cause |
| Implantation of a permanent pacemaker | 30 days | Incidence of Implantation of a permanent pacemaker |
| High-degree atrioventricular block (II or III) | 30 days | Incidence of High-degree atrioventricular block (II or III) |
| De novo or recurrent atrial fibrillation requiring a change in therapy | 30 days | Incidence of De novo or recurrent atrial fibrillation requiring a change in therapy |
| Time to pacemaker implantation or therapeutic change due to arrhythmia | 30 days | Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia |
| Resolution vs persistence of conduction disorders | 72 hours | Incidence of Resolution vs persistence of conduction disorders detected in the first 72 hours after TAVI implantation |
| QRS evolution: transient, persistent, or normalisation | 30 days | Incidence of QRS evolution: transient, persistent, or normalisation |
| Remote monitoring | 30 days | Percentage of time monitored correctly |
| hospital length to of stay from TAVI to discharge | At discharge | Duration of hospitalization post-TAVI procedure |
| Direct cost associated with stay and readmissions | 12 Months | Evaluation of Direct cost associated with hospital stay and readmissions |
| Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ) | 30 days | Quality of life assessed using (KCCQ)assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire developed to assess HRQoL (Health-Related Quality of Life) in patients with congestive heart failure. The KCCQ consists of five domains: physical limitation, symptoms (frequency, severity, and recent change over time), QoL (Quality of Life), social interference, and self-efficacy. The total score ranges from 0 to 100, and higher scores reflect better health status. |
Countries
Spain
Contacts
CONTACTBruno García del Blanco, MD, PhD
Outcome results
None listed