ClinicalTrials.gg
RecruitingNCT07456280IMPROVEUpdated Jul 22, 2026

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

An interventional study of Standard care and PhysioMem PM 100 4G ambulatory monitoring system in Severe Aortic Valve Stenosis and Cardiovascular Diseases, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 83 studies in Aortic Valve Stenosis with a site in Spain — 25 open to participants now, 32 under way, 1 of them phase 3. Aortic Valve Stenosis · Spain.

Planned enrollment
30th of 37
100 · median 209
Started
2026
with 3 others
No phase
26 of 83
12 open now
Primary completion
2028-07
later than 23 of 31 live
Registered
80th of 83
by date

Among the 83 studies in Aortic Valve Stenosis with a site in Spain, this one is the 30th largest by planned enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2026, is one of 26 with no phase, reaches primary completion later than 23 of the 31 other live ones, and was the 80th registered.

Aortic Valve Stenosis

1,026 studies on the registry are indexed under Aortic Valve Stenosis; 294 are open to participants now.

Browse Aortic Valve Stenosis studies →

Open to participants now

25 of the 83 studies in Aortic Valve Stenosis with a site in Spain are open now. Recruiting first, the newest first:

19 more — sign in →

All 25 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Get alerts for this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 83 studies in Aortic Valve Stenosis with a site in Spain, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Severe Aortic Valve Stenosis
  • Cardiovascular Diseases

Keywords

  • TAVI(Transcatheter Aortic Valve Implantation)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
  • \< 12 months due to non-cardiovascular comorbidity.
  • Refusal or inability to undergo outpatient follow-up.
  • Pregnant or breastfeeding.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • Active comparator
    Discharge according Standard Care

    Patients will be discharged from the hospital according standard care

    Behavioral: Standard care

Interventions

  • BehavioralStandard care

    Patients discharged according to standard care

  • DevicePhysioMem PM 100 4G ambulatory monitoring system

    Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. All-cause death

    Incidence of all-cause death

    Time frame: 30 days

  2. All-cause death

    Incidence of all-cause death

    Time frame: 12 months

  3. Unscheduled hospital readmission for any reason

    Incidence of unscheduled hospital readmission for any reason

    Time frame: 30 days

  4. Unscheduled hospital readmission for any reason

    Incidence of unscheduled hospital readmission for any reason

    Time frame: 12 months

  5. Cardiovascular death

    Incidence of cardiovascular death

    Time frame: 30 days

  6. Cardiovascular death

    Incidence of cardiovascular death

    Time frame: 12 months

  7. Hospital readmission due to cardiovascular cause

    Incidence of Hospital readmission due to cardiovascular cause

    Time frame: 30 days

  8. Hospital readmission due to cardiovascular cause

    Incidence of Hospital readmission due to cardiovascular cause

    Time frame: 12 months

  9. Implantation of a permanent pacemaker

    Incidence of Implantation of a permanent pacemaker

    Time frame: 30 days

  10. Implantation of a permanent pacemaker

    Incidence of Implantation of a permanent pacemaker

    Time frame: 12 months

  11. High-degree atrioventricular block (II or III)

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

    Time frame: 30 days

  12. 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

  13. 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

  14. 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

  15. 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

  16. QRS evolution: transient, persistent, or normalisation

    Incidence of QRS evolution: transient, persistent, or normalisation

    Time frame: 30 days

  17. Remote monitoring

    Percentage of time monitored correctly

    Time frame: 30 days

  18. hospital length to of stay from TAVI to discharge

    Duration of hospitalization post-TAVI procedure

    Time frame: At discharge

  19. Direct cost associated with stay and readmissions

    Evaluation of Direct cost associated with hospital stay and readmissions

    Time frame: 12 Months

  20. 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

  21. 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: 12 Months

07

Study locations

1 of 1 sites recruiting
  • Hospital Unniversitari Vall d'Hebron
    Barcelona, 08035, Spain
    Recruiting
08

References and documents

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 37762995 ↗
  • Mangieri 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 30018969 ↗
  • Tsoi 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 34132653 ↗
  • van 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 29688322 ↗
  • Piazza 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 20884435 ↗
  • Kooistra 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.

Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 23 months is below that.

Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2026
First posted
Mar 6, 2026
StartActual
Jul 20, 2026
Primary completionEst.
Jul 1, 2028
CompletionEst.
Aug 1, 2028
Last update
Jul 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07456280
Responsible party
Sponsor
First posted
Mar 6, 2026
Start date
Jul 20, 2026
Primary completion
Jul 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Jul 22, 2026

Study contacts

Bruno García del Blanco, MD, PhD
Contact
bruno.garcia@vallhebron.cat
00342746155

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion