Hospital Unniversitari Vall d'Hebron
Barcelona, 08035, Spain
Location status: Recruiting
Recruiting
NCT Number: NCT07456280
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 exclusion criteria must be met
- Immediate indication for permanent pacemaker following the procedure.
- Persistent complete atrioventricular block.
- QRS >160 msec and/or PR prolongation.
- Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge.
- Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system.
- Life expectancy < 12 months due to non-cardiovascular comorbidity.
- Refusal or inability to undergo outpatient follow-up.
- Pregnant or breastfeeding.
Treatment and study plan
Standard Care
BehavioralPatients discharged according to standard care
PhysioMem PM 100 4G ambulatory monitoring system
DevicePatients discharged with PhysioMem PM 100 4G ambulatory monitoring system
Primary outcomes
-
Composite of all-cause death and rehospitalization for any reason
Time frame: 30 days
Proportion of patients with:
- All cause of death
- Rehospitalization for any reason
-
Clinically relevant arrhythmic event requiring a change in therapy
Time frame: 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 outcomes
-
All-cause death
Time frame: 30 days
Incidence of all-cause death
-
All-cause death
Time frame: 12 months
Incidence of all-cause death
-
Unscheduled hospital readmission for any reason
Time frame: 30 days
Incidence of unscheduled hospital readmission for any reason
-
Unscheduled hospital readmission for any reason
Time frame: 12 months
Incidence of unscheduled hospital readmission for any reason
-
Cardiovascular death
Time frame: 30 days
Incidence of cardiovascular death
-
Cardiovascular death
Time frame: 12 months
Incidence of cardiovascular death
-
Hospital readmission due to cardiovascular cause
Time frame: 30 days
Incidence of Hospital readmission due to cardiovascular cause
-
Hospital readmission due to cardiovascular cause
Time frame: 12 months
Incidence of Hospital readmission due to cardiovascular cause
-
Implantation of a permanent pacemaker
Time frame: 30 days
Incidence of Implantation of a permanent pacemaker
-
Implantation of a permanent pacemaker
Time frame: 12 months
Incidence of Implantation of a permanent pacemaker
-
High-degree atrioventricular block (II or III)
Time frame: 30 days
Incidence of High-degree atrioventricular block (II or III)
-
De novo or recurrent atrial fibrillation requiring a change in therapy
Time frame: 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
Time frame: 30 days
Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia
-
Time to pacemaker implantation or therapeutic change due to arrhythmia
Time frame: 12 months
Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia
-
Resolution vs persistence of conduction disorders
Time frame: 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
Time frame: 30 days
Incidence of QRS evolution: transient, persistent, or normalisation
-
Remote monitoring
Time frame: 30 days
Percentage of time monitored correctly
-
hospital length to of stay from TAVI to discharge
Time frame: At discharge
Duration of hospitalization post-TAVI procedure
-
Direct cost associated with stay and readmissions
Time frame: 12 Months
Evaluation of Direct cost associated with hospital stay and readmissions
-
Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 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.
-
Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 12 Months
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Other
Registry information
Acronym: IMPROVE
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Mar 6, 2026
- Registry last updated
- Jul 22, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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