Systematic Ambulatory ECG Monitoring Following TAVI (RECORDII)
27 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
754
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Josep Rodes-Cabau, MD, PhD
- Numer telefonu: 14186568711
- E-mail: josep.rodes-cabau@criucpq.ulaval.ca
Kopia zapasowa kontaktu do badania
- Nazwa: Emilie Pelletier Beaumont, MSc
- Numer telefonu: 3929 4186568711
- E-mail: emilie.pelletier-beaumont@criucpq.ulaval
Lokalizacje studiów
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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
- Numer telefonu: 3929 4186568711
- E-mail: emilie.pelletier-beaumont@criucpq.ulaval.ca
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Główny śledczy:
- Josep Rodés-Cabau, MD, PhD
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Pod-śledczy:
- Francois Philippon, MD
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Incidence of sudden death
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 1 year after TAVI
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Cardiovascular mortality
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1 year after TAVI
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Josep Rodes-Cabau, MSc, Fondation IUCPQ
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
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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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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 sierpnia 2026
Zakończenie podstawowe (Szacowany)
1 grudnia 2028
Ukończenie studiów (Szacowany)
1 grudnia 2028
Daty rejestracji na studia
Pierwszy przesłany
21 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 lipca 2026
Pierwszy wysłany (Rzeczywisty)
31 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
31 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroba zastawki aortalnej
- Choroby układu krążenia
- Choroby serca
- Choroby zastawek serca
- Niedrożność odpływu komorowego
- Zwężenie zastawki aortalnej
- Techniki i procedury diagnostyczne
- Diagnoza
- Techniki diagnostyczne, sercowo -naczyniowe
- Testy funkcji serca
- Elektrodiagnoza
- Monitorowanie, fizjologiczne
- Elektrokardiografia
- Monitorowanie, ambulatoryjne
- Elektrokardiografia, ambulatoryjna
Inne numery identyfikacyjne badania
- RECORDII- MP-10-2026-4441
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .