Systematic Ambulatory ECG Monitoring Following TAVI (RECORDII)
27 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
754
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Josep Rodes-Cabau, MD, PhD
- Numéro de téléphone: 14186568711
- E-mail: josep.rodes-cabau@criucpq.ulaval.ca
Sauvegarde des contacts de l'étude
- Nom: Emilie Pelletier Beaumont, MSc
- Numéro de téléphone: 3929 4186568711
- E-mail: emilie.pelletier-beaumont@criucpq.ulaval
Lieux d'étude
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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
- Numéro de téléphone: 3929 4186568711
- E-mail: emilie.pelletier-beaumont@criucpq.ulaval.ca
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Chercheur principal:
- Josep Rodés-Cabau, MD, PhD
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Sous-enquêteur:
- Francois Philippon, MD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of sudden death
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 1 year after TAVI
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Cardiovascular mortality
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1 year after TAVI
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Josep Rodes-Cabau, MSc, Fondation IUCPQ
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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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.
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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.
- Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Aug 20;74(7):e51-e156. doi: 10.1016/j.jacc.2018.10.044. Epub 2018 Nov 6. No abstract available.
- 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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- Fischer Q, Urena M, Muntane-Carol G, Alperi A, Nombela-Franco L, Veiga G, Regueiro A, Suc G, Romaguera R, Avanzas P, Tirado-Conte G, de la Torre Hernandez JM, Cepas-Guillen P, Cote M, Philippon F, Rodes-Cabau J. Same-Day Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2025 Jul 28;18(14):1776-1785. doi: 10.1016/j.jcin.2025.05.041.
- Fischer Q, Nombela-Franco L, Muntane-Carol G, Veiga G, Regueiro A, Nazif T, Serra V, Asmarats L, Ribeiro HB, Latib A, Poulin A, Cheema AN, Jimenez-Quevedo P, Gomez-Hospital JA, Gil Ongay A, Ruberti A, Arzamendi D, Brener M, Calabuig A, Scotti A, Gelain MAS, Labinaz M, Cepas-Guillen P, Cote M, Del Portillo JH, Philippon F, Rodes-Cabau J. Risk of delayed atrioventricular block in patients without procedural conduction disturbances during transcatheter aortic valve replacement. Heart Rhythm. 2026 Apr;23(4):955-962. doi: 10.1016/j.hrthm.2025.04.017. Epub 2025 Apr 14.
- Natarajan MK, Sheth TN, Wijeysundera HC, Chavarria J, Rodes-Cabau J, Velianou JL, Radhakrishnan S, Newman T, Smith A, Wong JA, Schwalm JD, Duong M, Mian RI, Bishop MG, Healey JS. Remote ECG monitoring to reduce complications following transcatheter aortic valve implantations: the Redirect TAVI study. Europace. 2022 Oct 13;24(9):1475-1483. doi: 10.1093/europace/euac042.
- Muntane-Carol G, Okoh AK, Chen C, Nault I, Kassotis J, Mohammadi S, Coromilas J, Lee LY, Alperi A, Philippon F, Russo MJ, Rodes-Cabau J. Ambulatory Electrocardiographic Monitoring Following Minimalist Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2711-2722. doi: 10.1016/j.jcin.2021.08.039.
- Winter JL, Healey JS, Sheth TN, Velianou JL, Schwalm JD, Smith A, Reza S, Natarajan MK. Remote Ambulatory Cardiac Monitoring Before and After Transcatheter Aortic Valve Replacement. CJC Open. 2020 Apr 25;2(5):416-419. doi: 10.1016/j.cjco.2020.04.006. eCollection 2020 Sep.
- Skaf M, Makki N, Coressel A, Matre N, O'Neill S, Boudoulas K, Rushing G, Lilly SM. Rhythm Disturbances After Transcatheter Aortic Valve Replacement: A Strategy of Surveillance. Cardiovasc Revasc Med. 2020 Apr;21(4):475-478. doi: 10.1016/j.carrev.2019.07.017. Epub 2019 Jul 30. No abstract available.
- Tian Y, Padmanabhan D, McLeod CJ, Zhang P, Xiao P, Sandhu GS, Greason KL, Gulati R, Nkomo VT, Rihal CS, Polk LE, Sanvick C, Liu XP, Friedman PA, Cha YM. Utility of 30-Day Continuous Ambulatory Monitoring to Identify Patients With Delayed Occurrence of Atrioventricular Block After Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2019 Dec;12(12):e007635. doi: 10.1161/CIRCINTERVENTIONS.118.007635. Epub 2019 Dec 13.
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- Rodes-Cabau J, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre JM, Asmarats L, Pelletier-Beaumont E, Philippon F. Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1495-1505. doi: 10.1016/j.jcin.2018.04.016. Epub 2018 Jul 18.
- Steinberg JS, Varma N, Cygankiewicz I, Aziz P, Balsam P, Baranchuk A, Cantillon DJ, Dilaveris P, Dubner SJ, El-Sherif N, Krol J, Kurpesa M, La Rovere MT, Lobodzinski SS, Locati ET, Mittal S, Olshansky B, Piotrowicz E, Saxon L, Stone PH, Tereshchenko L, Turitto G, Wimmer NJ, Verrier RL, Zareba W, Piotrowicz R. 2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry. Heart Rhythm. 2017 Jul;14(7):e55-e96. doi: 10.1016/j.hrthm.2017.03.038. Epub 2017 May 8.
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- Muntane-Carol G, Urena M, Munoz-Garcia A, Padron R, Gutierrez E, Regueiro A, Serra V, Capretti G, Himbert D, Moris C, Sabate M, Garcia Del Blanco B, Ferreira-Neto AN, Cote M, Fischer Q, Couture T, Kalavrouziotis D, Rodes-Cabau J. Late Cerebrovascular Events Following Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Apr 13;13(7):872-881. doi: 10.1016/j.jcin.2019.11.022. Epub 2020 Mar 11.
- Nombela-Franco L, Webb JG, de Jaegere PP, Toggweiler S, Nuis RJ, Dager AE, Amat-Santos IJ, Cheung A, Ye J, Binder RK, van der Boon RM, Van Mieghem N, Benitez LM, Perez S, Lopez J, San Roman JA, Doyle D, Delarochelliere R, Urena M, Leipsic J, Dumont E, Rodes-Cabau J. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation. 2012 Dec 18;126(25):3041-53. doi: 10.1161/CIRCULATIONAHA.112.110981. Epub 2012 Nov 13.
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- Jorgensen TH, De Backer O, Gerds TA, Bieliauskas G, Svendsen JH, Sondergaard L. Immediate Post-Procedural 12-Lead Electrocardiography as Predictor of Late Conduction Defects After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1509-1518. doi: 10.1016/j.jcin.2018.04.011.
- Mangieri A, Lanzillo G, Bertoldi L, Jabbour RJ, Regazzoli D, Ancona MB, Tanaka A, Mitomo S, Garducci S, Montalto C, Pagnesi M, Giannini F, Giglio M, Montorfano M, Chieffo A, Rodes-Cabau J, Monaco F, Paglino G, Della Bella P, Colombo A, Latib A. Predictors of Advanced Conduction Disturbances Requiring a Late (>/=48 H) Permanent Pacemaker Following Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1519-1526. doi: 10.1016/j.jcin.2018.06.014.
- 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.
- Wood DA, Lauck SB, Cairns JA, Humphries KH, Cook R, Welsh R, Leipsic J, Genereux P, Moss R, Jue J, Blanke P, Cheung A, Ye J, Dvir D, Umedaly H, Klein R, Rondi K, Poulter R, Stub D, Barbanti M, Fahmy P, Htun N, Murdoch D, Prakash R, Barker M, Nickel K, Thakkar J, Sathananthan J, Tyrell B, Al-Qoofi F, Velianou JL, Natarajan MK, Wijeysundera HC, Radhakrishnan S, Horlick E, Osten M, Buller C, Peterson M, Asgar A, Palisaitis D, Masson JB, Kodali S, Nazif T, Thourani V, Babaliaros VC, Cohen DJ, Park JE, Leon MB, Webb JG. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):459-469. doi: 10.1016/j.jcin.2018.12.020.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 décembre 2028
Achèvement de l'étude (Estimé)
1 décembre 2028
Dates d'inscription aux études
Première soumission
21 juillet 2026
Première soumission répondant aux critères de contrôle qualité
27 juillet 2026
Première publication (Réel)
31 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladie de la valve aortique
- Maladies cardiovasculaires
- Maladies cardiaques
- Maladies des valves cardiaques
- Obstruction de la sortie ventriculaire
- Sténose valvulaire aortique
- Techniques et procédures de diagnostic
- Diagnostic
- Techniques de diagnostic, cardiovasculaire
- Tests de la fonction cardiaque
- Électrodiagnostic
- Surveillance, physiologique
- Électrocardiographie
- Surveillance, ambulatoire
- Électrocardiographie, ambulatoire
Autres numéros d'identification d'étude
- RECORDII- MP-10-2026-4441
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .