Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)

Hospital Universitari Vall d'Hebron Research Institute100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Severe Aortic Valve Stenosis Cardiovascular Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Composite of all-cause death and rehospitalization for any reason

Proportion of patients with: * All cause of death * Rehospitalization for any reason

Time frame: 30 days

Clinically relevant arrhythmic event requiring a change in therapy

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

Time frame: 30 days

Secondary Outcomes

All-cause death

Incidence of all-cause death

Time frame: 30 days

All-cause death

Incidence of all-cause death

Time frame: 12 months

Unscheduled hospital readmission for any reason

Incidence of unscheduled hospital readmission for any reason

Time frame: 30 days

Unscheduled hospital readmission for any reason

Incidence of unscheduled hospital readmission for any reason

Time frame: 12 months

Cardiovascular death

Incidence of cardiovascular death

Time frame: 30 days

Cardiovascular death

Incidence of cardiovascular death

Time frame: 12 months

Hospital readmission due to cardiovascular cause

Incidence of Hospital readmission due to cardiovascular cause

Time frame: 30 days

Hospital readmission due to cardiovascular cause

Incidence of Hospital readmission due to cardiovascular cause

Time frame: 12 months

Implantation of a permanent pacemaker

Incidence of Implantation of a permanent pacemaker

Time frame: 30 days

Implantation of a permanent pacemaker

Incidence of Implantation of a permanent pacemaker

Time frame: 12 months

High-degree atrioventricular block (II or III)

Incidence of High-degree atrioventricular block (II or III)

Time frame: 30 days

De novo or recurrent atrial fibrillation requiring a change in therapy

Incidence of De novo or recurrent atrial fibrillation requiring a change in therapy

Time frame: 30 days

Time to pacemaker implantation or therapeutic change due to arrhythmia

Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia

Time frame: 30 days

Time to pacemaker implantation or therapeutic change due to arrhythmia

Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia

Time frame: 12 months

Resolution vs persistence of conduction disorders

Incidence of Resolution vs persistence of conduction disorders detected in the first 72 hours after TAVI implantation

Time frame: 72 hours

QRS evolution: transient, persistent, or normalisation

Incidence of QRS evolution: transient, persistent, or normalisation

Time frame: 30 days

Remote monitoring

Percentage of time monitored correctly

Time frame: 30 days

hospital length to of stay from TAVI to discharge

Duration of hospitalization post-TAVI procedure

Time frame: At discharge

Direct cost associated with stay and readmissions

Evaluation of Direct cost associated with hospital stay and readmissions

Time frame: 12 Months

Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ)

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.

Time frame: 30 days

Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time frame: 12 Months

Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts