Systematic Ambulatory ECG Monitoring Following TAVI (RECORDII)
27 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
754
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Josep Rodes-Cabau, MD, PhD
- Telefonnummer: 14186568711
- E-post: josep.rodes-cabau@criucpq.ulaval.ca
Studera Kontakt Backup
- Namn: Emilie Pelletier Beaumont, MSc
- Telefonnummer: 3929 4186568711
- E-post: emilie.pelletier-beaumont@criucpq.ulaval
Studieorter
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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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Kontakt:
- Emilie Pelletier beaumont, MSc
- Telefonnummer: 3929 4186568711
- E-post: emilie.pelletier-beaumont@criucpq.ulaval.ca
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Huvudutredare:
- Josep Rodés-Cabau, MD, PhD
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Underutredare:
- Francois Philippon, MD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of sudden death
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1 year after TAVI
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Cardiovascular mortality
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1 year after TAVI
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Josep Rodes-Cabau, MSc, Fondation IUCPQ
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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- 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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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
1 december 2028
Avslutad studie (Beräknad)
1 december 2028
Studieregistreringsdatum
Först inskickad
21 juli 2026
Först inskickad som uppfyllde QC-kriterierna
27 juli 2026
Första postat (Faktisk)
31 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Aortaklaffssjukdom
- Hjärt-kärlsjukdomar
- Hjärtsjukdom
- Hjärtklaffssjukdomar
- Ventrikulärt utflödeshinder
- Aortaklaffstenos
- Diagnostiska tekniker och procedurer
- Diagnos
- Diagnostiska tekniker, hjärt -kärl
- Hjärtfunktionstester
- Elektrodiagnos
- Övervakning, fysiologisk
- Elektrokardiografi
- Övervakning, ambulant
- Elektrokardiografi, ambulant
Andra studie-ID-nummer
- RECORDII- MP-10-2026-4441
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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