Evaluation of the Non-invasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorder Through TAVI Implantation (IMPROVE)

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 Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Severe Aortic Valve Stenosis
• Intervention / Treatment: Device: PhysioMem PM 100 4G ambulatory monitoring system; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno García del Blanco, MD, PhD; Phone Number: 00342746155; Email: bruno.garcia@vallhebron.cat

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Unniversitari Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early discharge (24 hours post-TAVI); Patients will be discharged from the hospital 24 hours post-TAVI with PhysioMem PM 100 4G ambulatory monitoring system.	Device: PhysioMem PM 100 4G ambulatory monitoring system; Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system
Active Comparator: Discharge according Standard Care; Patients will be discharged from the hospital according standard care	Behavioral: Standard care; Patients discharged according to standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause death and rehospitalization for any reason	Proportion of patients with: All cause of death; Rehospitalization for any reason	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Incidence of all-cause death	30 days
All-cause death	Incidence of all-cause death	12 months
Unscheduled hospital readmission for any reason	Incidence of unscheduled hospital readmission for any reason	30 days
Unscheduled hospital readmission for any reason	Incidence of unscheduled hospital readmission for any reason	12 months
Cardiovascular death	Incidence of cardiovascular death	30 days
Cardiovascular death	Incidence of cardiovascular death	12 months
Hospital readmission due to cardiovascular cause	Incidence of Hospital readmission due to cardiovascular cause	30 days
Hospital readmission due to cardiovascular cause	Incidence of Hospital readmission due to cardiovascular cause	12 months
Implantation of a permanent pacemaker	Incidence of Implantation of a permanent pacemaker	30 days
Implantation of a permanent pacemaker	Incidence of Implantation of a permanent pacemaker	12 months
High-degree atrioventricular block (II or III)	Incidence of High-degree atrioventricular block (II or III)	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	30 days
Time to pacemaker implantation or therapeutic change due to arrhythmia	Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia	30 days
Time to pacemaker implantation or therapeutic change due to arrhythmia	Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia	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	72 hours
QRS evolution: transient, persistent, or normalisation	Incidence of QRS evolution: transient, persistent, or normalisation	30 days
Remote monitoring	Percentage of time monitored correctly	30 days
hospital length to of stay from TAVI to discharge	Duration of hospitalization post-TAVI procedure	At discharge
Direct cost associated with stay and readmissions	Evaluation of Direct cost associated with hospital stay and readmissions	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.	30 days
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.	12 Months

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General Publications

• Szotek M, Drużbicki Ł, Sabatowski K, Amoroso GR, De Schouwer K, Matusik PT. Transcatheter Aortic Valve Implantation and Cardiac Conduction Abnormalities: Prevalence, Risk Factors and Management. J Clin Med. 19 September 2023;12(18):6056.
• Mangieri A, Montalto C, Pagnesi M, Lanzillo G, Demir O, Testa L, et al. TAVI and Post Procedural Cardiac Conduction Abnormalities. Front Cardiovasc Med. 3 July 2018;5:85.
• Tsoi M, Tandon K, Zimetbaum PJ, Frishman WH. Conduction Disturbances and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: Predictors and Prevention. Cardiol Rev. July 2022;30(4):179-87
• Van Gils L, Baart S, Kroon H, Rahhab Z, El Faquir N, Rodriguez Olivares R, et al. Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT study. EP Eur. 1 December 2018;20(12):1981-8.
• Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, García-García H, et al. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation. EuroIntervention. September 2010;6(4):475-84.
• Kooistra NHM, Van Mourik MS, Rodriguez-Olivares R, Maass AH, Nijenhuis VJ, Van De Werf H, et al. P3856Timing and associated predictors of onset of new conduction disturbances requiring permanent pacemaker implantation after transcatheter aortic valve implantation. Eur Heart J. 1 October 2019;40(Supplement_1):ehz745.0694.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: TAVI(Transcatheter Aortic Valve Implantation)
• Additional Relevant MeSH Terms: Aortic Valve Disease; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Cardiovascular Diseases; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IMPROVE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No