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Recruiting NCT07456280

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

No phase Interventional Severe Aortic Valve Stenosis Cardiovascular Diseases

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard care, PhysioMem PM 100 4G ambulatory monitoring system.
Who it may be relevant to
Registry conditions: Severe Aortic Valve Stenosis, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Interventions

  • Behavioral Standard care
    Patients discharged according to standard care
  • Device PhysioMem PM 100 4G ambulatory monitoring system
    Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system

Primary outcome measures

  • Composite of all-cause death and rehospitalization for any reason [Time frame: 30 days]
  • Clinically relevant arrhythmic event requiring a change in therapy [Time frame: 30 days]
Secondary outcome measures (12)
  • All-cause death [Time frame: 30 days]
  • All-cause death [Time frame: 12 months]
  • Unscheduled hospital readmission for any reason [Time frame: 30 days]
  • Unscheduled hospital readmission for any reason [Time frame: 12 months]
  • Cardiovascular death [Time frame: 30 days]
  • Cardiovascular death [Time frame: 12 months]
  • Hospital readmission due to cardiovascular cause [Time frame: 30 days]
  • Hospital readmission due to cardiovascular cause [Time frame: 12 months]
  • Implantation of a permanent pacemaker [Time frame: 30 days]
  • Implantation of a permanent pacemaker [Time frame: 12 months]
  • High-degree atrioventricular block (II or III) [Time frame: 30 days]
  • De novo or recurrent atrial fibrillation requiring a change in therapy [Time frame: 30 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Spain · 1 center
  • Hospital Unniversitari Vall d'Hebron — Barcelona

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 32005676

Identifiers

NCT: NCT07456280 · IMPROVE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗