Severe Aortic Valve StenosisIMPROVENCT07456280
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
A study testing PhysioMem PM 100 4G ambulatory monitoring system in people with Severe Aortic Valve Stenosis and Cardiovascular Diseases, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis, Cardiovascular Diseases
- What is being tested?
- PhysioMem PM 100 4G ambulatory monitoring system
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2026to 1 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Life expectancy < 12 months due to non-cardiovascular comorbidity.
- Refusal or inability to undergo outpatient follow-up.
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Unniversitari Vall d'Hebron
Barcelona, 08035
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.
Read the 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.
- Being tested
- Standard care, PhysioMem PM 100 4G ambulatory monitoring system
- Keywords
- TAVI(Transcatheter Aortic Valve Implantation)
- Medical subject headings
- Aortic Valve Stenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careBehavioural
Patients discharged according to standard care
PhysioMem PM 100 4G ambulatory monitoring systemDevice
Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system
| Study group | Role | What they receive |
|---|---|---|
| Early discharge (24 hours post-TAVI) | Experimental | Patients will be discharged from the hospital 24 hours post-TAVI with PhysioMem PM 100 4G ambulatory monitoring system. Receives: Device: PhysioMem PM 100 4G ambulatory monitoring system |
| Discharge according Standard Care | Active comparator | Patients will be discharged from the hospital according standard care Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause death and rehospitalization for any reason
Proportion of patients with:
- All cause of death
- Rehospitalization for any reason
Measured: 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
Measured: 30 days
Secondary outcomes (21)
All-cause death
Incidence of all-cause death
Measured: 30 days
All-cause death
Incidence of all-cause death
Measured: 12 months
Unscheduled hospital readmission for any reason
Incidence of unscheduled hospital readmission for any reason
Measured: 30 days
Unscheduled hospital readmission for any reason
Incidence of unscheduled hospital readmission for any reason
Measured: 12 months
Cardiovascular death
Incidence of cardiovascular death
Measured: 30 days
Cardiovascular death
Incidence of cardiovascular death
Measured: 12 months
Hospital readmission due to cardiovascular cause
Incidence of Hospital readmission due to cardiovascular cause
Measured: 30 days
Hospital readmission due to cardiovascular cause
Incidence of Hospital readmission due to cardiovascular cause
Measured: 12 months
Implantation of a permanent pacemaker
Incidence of Implantation of a permanent pacemaker
Measured: 30 days
Implantation of a permanent pacemaker
Incidence of Implantation of a permanent pacemaker
Measured: 12 months
High-degree atrioventricular block (II or III)
Incidence of High-degree atrioventricular block (II or III)
Measured: 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
Measured: 30 days
Time to pacemaker implantation or therapeutic change due to arrhythmia
Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia
Measured: 30 days
Time to pacemaker implantation or therapeutic change due to arrhythmia
Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia
Measured: 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
Measured: 72 hours
QRS evolution: transient, persistent, or normalisation
Incidence of QRS evolution: transient, persistent, or normalisation
Measured: 30 days
Remote monitoring
Percentage of time monitored correctly
Measured: 30 days
hospital length to of stay from TAVI to discharge
Duration of hospitalization post-TAVI procedure
Measured: At discharge
Direct cost associated with stay and readmissions
Evaluation of Direct cost associated with hospital stay and readmissions
Measured: 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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start20 Jul 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456280
- Sponsor's protocol ID
- IMPROVE
- Acronym
- IMPROVE
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Szotek M, Druzbicki L, 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. 2023 Sep 19;12(18):6056. doi: 10.3390/jcm12186056.
PubMed 37762995Mangieri A, Montalto C, Pagnesi M, Lanzillo G, Demir O, Testa L, Colombo A, Latib A. TAVI and Post Procedural Cardiac Conduction Abnormalities. Front Cardiovasc Med. 2018 Jul 3;5:85. doi: 10.3389/fcvm.2018.00085. eCollection 2018.
PubMed 30018969Tsoi M, Tandon K, Zimetbaum PJ, Frishman WH. Conduction Disturbances and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: Predictors and Prevention. Cardiol Rev. 2022 Jul-Aug 01;30(4):179-187. doi: 10.1097/CRD.0000000000000398. Epub 2021 Jun 14.
PubMed 34132653van Gils L, Baart S, Kroon H, Rahhab Z, El Faquir N, Rodriguez Olivares R, Aga Y, Maugenest AM, Theuns DA, Boersma E, Szili Torok T, De Jaegere PP, Van Mieghem NM. Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study. Europace. 2018 Dec 1;20(12):1981-1988. doi: 10.1093/europace/euy074.
PubMed 29688322Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, Garcia-Garcia H, Schultz C, van Domburg R, van Es GA, van Geuns R, de Jaegere P, Serruys PW. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation. EuroIntervention. 2010 Sep;6(4):475-84. doi: 10.4244/EIJ30V6I4A80.
PubMed 20884435Kooistra NHM, van Mourik MS, Rodriguez-Olivares R, Maass AH, Nijenhuis VJ, van der Werf R, Ten Berg JM, Kraaijeveld AO, Baan J Jr, Voskuil M, Vis MM, Stella PR. Late onset of new conduction disturbances requiring permanent pacemaker implantation following TAVI. Heart. 2020 Aug;106(16):1244-1251. doi: 10.1136/heartjnl-2019-315967. Epub 2020 Jan 31.
PubMed 32005676