Evaluation of the Non-invasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorder Through TAVI Implantation
IMPROVE
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
March 6, 2026
March 1, 2026
2.3 years
February 25, 2026
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (21)
All-cause death
30 days
All-cause death
12 months
Unscheduled hospital readmission for any reason
30 days
Unscheduled hospital readmission for any reason
12 months
Cardiovascular death
30 days
- +16 more secondary outcomes
Study Arms (2)
Early discharge (24 hours post-TAVI)
EXPERIMENTALPatients will be discharged from the hospital 24 hours post-TAVI with PhysioMem PM 100 4G ambulatory monitoring system.
Discharge according Standard Care
ACTIVE COMPARATORPatients will be discharged from the hospital according standard care
Interventions
Patients discharged according to standard care
Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Unniversitari Vall d'Hebron
Barcelona, 08035, Spain
Related Publications (6)
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.
BACKGROUNDMangieri 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.
BACKGROUNDTsoi 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
BACKGROUNDVan 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.
BACKGROUNDPiazza 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.
BACKGROUNDKooistra 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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 6, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
March 6, 2026
Record last verified: 2026-03