Systematic Ambulatory ECG Monitoring Following TAVI (RECORDII)
maanantai 27. heinäkuuta 2026 päivittänyt: Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Systematic Ambulatory ECG Monitoring Following TAVI: A Prospective Randomized Trial.
This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of sudden death, symptomatic arrhythmic events, or stroke within 1 year compared with standard post-discharge care.
Patients undergoing successful TAVI without permanent pacemaker implantation and presenting with at least one ECG conduction abnormality at hospital discharge will be randomized to receive either ambulatory ECG monitoring or standard follow-up.
All participants will undergo routine clinical follow-up at 30 days and 1 year after TAVI.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite advances in transcatheter heart valve technology and procedural techniques, conduction disturbances remain among the most frequent complications following TAVI. High-grade atrioventricular block, complete heart block, and new-onset bundle branch block may occur after the procedure and can lead to delayed permanent pacemaker implantation or life-threatening arrhythmic events. The increasing adoption of minimalist TAVI pathways with hospital discharge within 24-72 hours raises concerns that clinically significant arrhythmias may develop after discharge and remain undetected.
Ambulatory electrocardiographic (ECG) monitoring provides continuous rhythm surveillance during daily activities and enables the early detection of both symptomatic and asymptomatic bradyarrhythmias and tachyarrhythmias. Previous observational studies have demonstrated that clinically significant bradyarrhythmias occur in approximately 5-10% of patients during the first weeks after TAVI, particularly among those with baseline or new-onset conduction abnormalities. Ambulatory ECG monitoring has also identified previously unrecognized atrial fibrillation, allowing timely initiation of anticoagulation therapy in patients at high risk of thromboembolic events.
Although several prospective studies have evaluated ambulatory ECG monitoring after TAVI, most have been observational and were designed primarily to describe the incidence of post-procedural arrhythmias rather than to assess their impact on clinical outcomes. Preliminary evidence from the RECORD pilot study suggested that systematic ambulatory ECG monitoring after hospital discharge was associated with earlier identification and treatment of clinically significant arrhythmias and a reduction in the composite of sudden death, symptomatic arrhythmic events, and stroke during 1-year follow-up, with the greatest benefit observed among patients with conduction abnormalities at hospital discharge.
This randomized trial has been designed to provide definitive evidence regarding the clinical value of systematic ambulatory ECG monitoring after TAVI in patients at increased risk of post-procedural conduction disturbances. The study will evaluate whether early detection and management of clinically significant arrhythmias can improve clinical outcomes during the year following the procedure.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
754
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Josep Rodes-Cabau, MD, PhD
- Puhelinnumero: 14186568711
- Sähköposti: josep.rodes-cabau@criucpq.ulaval.ca
Tutki yhteystietojen varmuuskopiointi
- Nimi: Emilie Pelletier Beaumont, MSc
- Puhelinnumero: 3929 4186568711
- Sähköposti: emilie.pelletier-beaumont@criucpq.ulaval
Opiskelupaikat
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Quebec
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Québec, Quebec, Kanada, G1Y 4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - UL
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Ottaa yhteyttä:
- Emilie Pelletier beaumont, MSc
- Puhelinnumero: 3929 4186568711
- Sähköposti: emilie.pelletier-beaumont@criucpq.ulaval.ca
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Päätutkija:
- Josep Rodés-Cabau, MD, PhD
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Alatutkija:
- Francois Philippon, MD
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Inclusion Criteria:
- Age >18 years
- Successful TAVI procedure.
- Hospitalization discharge ≤72 hrs following the TAVI procedure.
- Presence of at least 1 ECG abnormality at hospital discharge (QRS ≥120 ms OR PR ≥200 ms)
Exclusion Criteria:
- Pacemaker implantation (pre- TAVI or during hospitalization after the procedure).
- TAVI valve-in-valve procedure
- Any complication or logistic reason precluding hospital discharge ≤72 hrs following the TAVI procedure.
- Impossibility to obtain signed informed consent.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Ambulatory ECG monitoring
Participants will undergo ambulatory ECG monitoring at hospital discharge following TAVI.
Continuous ECG monitoring will be performed for 14 days using an ambulatory ECG monitoring device.
Clinically significant bradyarrhythmias or tachyarrhythmias detected during monitoring will be reviewed and managed according to clinical practice, including appropriate therapeutic interventions when indicated.
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Participants randomized to the intervention arm will undergo systematic ambulatory ECG monitoring at hospital discharge following the TAVI procedure.
A wearable ambulatory ECG monitoring device will be applied for continuous rhythm monitoring during a 14-day period.
The device will allow detection of clinically significant bradyarrhythmias and tachyarrhythmias.
Detected arrhythmic events will be reviewed by the study team, and appropriate clinical management, including further evaluation or therapeutic intervention, will be performed according to the nature of the detected abnormality and standard clinical practice.
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Ei väliintuloa: Standard care (no ambulatory ECG monitoring device).
Participants will receive standard post-TAVI care without systematic ambulatory ECG monitoring at hospital discharge.
Clinical follow-up will be performed according to routine practice.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)
Aikaikkuna: Within the year following the TAVI procedure
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Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.
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Within the year following the TAVI procedure
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Incidence of sudden death
Aikaikkuna: 1 year after TAVI
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Sudden death
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1 year after TAVI
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Incidence of symptomatic arrhythmias
Aikaikkuna: 1 year after TAVI
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All symptomatic arrhythmias events
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1 year after TAVI
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Incidence of stroke
Aikaikkuna: 1 year after TAVI
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All stroke events
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1 year after TAVI
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Incidence of PPI
Aikaikkuna: 30 days after TAVI
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Number of patients with PPI
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30 days after TAVI
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Incidence of PPI
Aikaikkuna: 1 year after TAVI
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Number of patients with PPI
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1 year after TAVI
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Incidence of the combined endpoint (sudden death, symptomatic arrhythmias or stroke) at 30 days
Aikaikkuna: 30 days after TAVI
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Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.
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30 days after TAVI
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Incidence of sudden death
Aikaikkuna: 30 days after TAVI
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Sudden death
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30 days after TAVI
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Incidence of symptomatic arrhytmias
Aikaikkuna: 30 days after TAVI
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All symptomatic arrhythmias events
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30 days after TAVI
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Incidence of stroke
Aikaikkuna: 30 days after TAVI
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All stroke events
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30 days after TAVI
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Incidence of the combined endpoint (sudden death, symptomatic arrhythmias, stroke) according to patient sex
Aikaikkuna: 1 year after TAVI
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Composite endpoint including sudden death, symptomatic arrhythmias, or stroke, analyzed according to patient sex.
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1 year after TAVI
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Incidence of the combined endpoint of sudden death, symptomatic arrhythmias, or stroke) according to ECG abnormalities
Aikaikkuna: 1 year after TAVI
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Composite endpoint including sudden death, symptomatic arrhythmias, or stroke, analyzed according to ECG abnormality status (pre-existing versus new-onset after TAVI).
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1 year after TAVI
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Incidence of the combined endpoint according to baseline ECG abnormality type
Aikaikkuna: 1 year after TAVI
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Composite endpoint (sudden death, symptomatic arrhythmias, or stroke) analyzed according to the type of ECG abnormality present before TAVI.
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1 year after TAVI
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Incidence of sudden death according to baseline ECG abnormality type
Aikaikkuna: 1 year after TAVI
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Sudden death analyzed according to the type of ECG abnormality present before TAVI.
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1 year after TAVI
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Incidence of symptomatic arrhythmias according to baseline ECG abnormality type
Aikaikkuna: 1 year after TAVI
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Symptomatic arrhythmias according to the type of ECG abnormality present before TAVI.
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1 year after TAVI
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Incidence of stroke according to baseline ECG abnormality type
Aikaikkuna: 1 year after TAVI
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Stroke according to the type of ECG abnormality present before TAVI.
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1 year after TAVI
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Incidence of the combined endpoint according to discharge ECG abnormality type
Aikaikkuna: 1 year after TAVI
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Composite endpoint (sudden death, symptomatic arrhythmias, or stroke) according to the type of ECG abnormality present at hospital discharge.
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1 year after TAVI
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Incidence of sudden death according to discharge ECG abnormality type
Aikaikkuna: 1 year after TAVI
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Sudden death according to the type of ECG abnormality present at hospital discharge.
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1 year after TAVI
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Incidence of symptomatic arrhythmias according to discharge ECG abnormality type
Aikaikkuna: 1 year after TAVI
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Symptomatic arrhythmias according to the type of ECG abnormality present at hospital discharge.
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1 year after TAVI
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Incidence of stroke according to discharge ECG abnormality type
Aikaikkuna: 1 year after TAVI
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Stroke according to the type of ECG abnormality present at hospital discharge.
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1 year after TAVI
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Change in quality of life
Aikaikkuna: Baseline to 1 year after TAVI
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Quality of life assessed using the EQ-5D-5L questionnaire.
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Baseline to 1 year after TAVI
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Percentage of ventricular pacing
Aikaikkuna: 1 year after TAVI
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Ventricular pacing burden in participants with permanent pacemakers.
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1 year after TAVI
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Incidence of all-cause mortality
Aikaikkuna: 30 days after TAVI
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All-cause mortality
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30 days after TAVI
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Incidence of cardiovascular mortality
Aikaikkuna: 30 days after TAVI
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Cardiovascular mortality
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30 days after TAVI
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Incidence of all-cause mortality
Aikaikkuna: 1 year after TAVI
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All cause mortality
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1 year after TAVI
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Incidence of cardiovasculare mortality
Aikaikkuna: 1 year after TAVI
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Cardiovascular mortality
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1 year after TAVI
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Josep Rodes-Cabau, MSc, Fondation IUCPQ
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
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Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Lauantai 1. elokuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Perjantai 1. joulukuuta 2028
Opintojen valmistuminen (Arvioitu)
Perjantai 1. joulukuuta 2028
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 21. heinäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 27. heinäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Perjantai 31. heinäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 31. heinäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 27. heinäkuuta 2026
Viimeksi vahvistettu
Keskiviikko 1. heinäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Aorttaläppäsairaus
- Sydän-ja verisuonitaudit
- Sydänsairaudet
- Sydänläppäsairaudet
- Kammion ulosvirtauksen estäminen
- Aorttaläppästenoosi
- Diagnostiikkatekniikat ja menettelyt
- Diagnoosi
- Diagnostiikkatekniikat, sydän-
- Sydämen toimintakokeet
- Elektrodiagnoosi
- Seuranta, fysiologinen
- Elektrokardiografia
- Seuranta, ambulatorinen
- Elektrokardiografia, ambulatorinen
Muut tutkimustunnusnumerot
- RECORDII- MP-10-2026-4441
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
PÄÄTTÄMÄTÖN
IPD-suunnitelman kuvaus
A decision regarding IPD sharing has not yet been made.
Following study completion, requests for access to de-identified individual participant data may be considered by the sponsor on a case-by-case basis, subject to ethical, legal, and institutional requirements.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .