Systematic Ambulatory ECG Monitoring Following TAVI (RECORDII)
27 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
754
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Josep Rodes-Cabau, MD, PhD
- Telefoonnummer: 14186568711
- E-mail: josep.rodes-cabau@criucpq.ulaval.ca
Studie Contact Back-up
- Naam: Emilie Pelletier Beaumont, MSc
- Telefoonnummer: 3929 4186568711
- E-mail: emilie.pelletier-beaumont@criucpq.ulaval
Studie Locaties
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Quebec
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Québec, Quebec, Canada, G1Y 4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - UL
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Contact:
- Emilie Pelletier beaumont, MSc
- Telefoonnummer: 3929 4186568711
- E-mail: emilie.pelletier-beaumont@criucpq.ulaval.ca
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Hoofdonderzoeker:
- Josep Rodés-Cabau, MD, PhD
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Onderonderzoeker:
- Francois Philippon, MD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of sudden death
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 1 year after TAVI
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Cardiovascular mortality
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1 year after TAVI
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Josep Rodes-Cabau, MSc, Fondation IUCPQ
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
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- Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2018 Sep 25;138(13):e210-e271. doi: 10.1161/CIR.0000000000000548. No abstract available.
- Kaplan RM, Koehler J, Ziegler PD, Sarkar S, Zweibel S, Passman RS. Stroke Risk as a Function of Atrial Fibrillation Duration and CHA2DS2-VASc Score. Circulation. 2019 Nov 12;140(20):1639-1646. doi: 10.1161/CIRCULATIONAHA.119.041303. Epub 2019 Sep 30.
- Writing Committee Members; Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024 Jan 2;83(1):109-279. doi: 10.1016/j.jacc.2023.08.017. Epub 2023 Nov 30.
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- Nuche J, Soliman F, Chavarria J, Okoh AK, Alvarado Mora H, Nault I, Natarajan MK, Russo M, Philippon F, Rodes-Cabau J. New-onset atrial fibrillation detected by ambulatory ECG monitoring after transcatheter aortic valve implantation. EuroIntervention. 2024 May 10;20(9):591-601. doi: 10.4244/EIJ-D-23-01014.
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- 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.
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- Rodes-Cabau J, Ellenbogen KA, Krahn AD, Latib A, Mack M, Mittal S, Muntane-Carol G, Nazif TM, Sondergaard L, Urena M, Windecker S, Philippon F. Management of Conduction Disturbances Associated With Transcatheter Aortic Valve Replacement: JACC Scientific Expert Panel. J Am Coll Cardiol. 2019 Aug 27;74(8):1086-1106. doi: 10.1016/j.jacc.2019.07.014.
- Nuche J, Ellenbogen KA, Mittal S, Windecker S, Benavent C, Philippon F, Rodes-Cabau J. Conduction Disturbances After Transcatheter Aortic Valve Replacement: An Update on Epidemiology, Preventive Strategies, and Management. JACC Cardiovasc Interv. 2024 Nov 25;17(22):2575-2595. doi: 10.1016/j.jcin.2024.07.032.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
1 december 2028
Studie voltooiing (Geschat)
1 december 2028
Studieregistratiedata
Eerst ingediend
21 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 juli 2026
Eerst geplaatst (Werkelijk)
31 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
27 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekte van de aortaklep
- Hart-en vaatziekten
- Hartziekten
- Ziekten van de hartklep
- Ventriculaire uitstroomobstructie
- Aortaklepstenose
- Diagnostische technieken en procedures
- Diagnose
- Diagnostische technieken, cardiovasculair
- Hartfunctietests
- Elektrodiagnose
- Monitoring, fysiologisch
- Elektrocardiografie
- Monitoring, ambulant
- Elektrocardiografie, ambulant
Andere studie-ID-nummers
- RECORDII- MP-10-2026-4441
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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