Systematic Ambulatory ECG Monitoring Following TAVI

Официальное название

Systematic Ambulatory ECG Monitoring Following TAVI: A Prospective Randomized Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Ambulatory ECG monitoring
  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 ther

Первичные конечные точки

• Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke) [Срок оценки: Within the year following the TAVI procedure]

Вторичные конечные точки (12)

• Incidence of sudden death [Срок оценки: 1 year after TAVI]
• Incidence of symptomatic arrhythmias [Срок оценки: 1 year after TAVI]
• Incidence of stroke [Срок оценки: 1 year after TAVI]
• Incidence of PPI [Срок оценки: 30 days after TAVI]
• Incidence of PPI [Срок оценки: 1 year after TAVI]
• Incidence of the combined endpoint (sudden death, symptomatic arrhythmias or stroke) at 30 days [Срок оценки: 30 days after TAVI]
• Incidence of sudden death [Срок оценки: 30 days after TAVI]
• Incidence of symptomatic arrhytmias [Срок оценки: 30 days after TAVI]
• Incidence of stroke [Срок оценки: 30 days after TAVI]
• Incidence of the combined endpoint (sudden death, symptomatic arrhythmias, stroke) according to patient sex [Срок оценки: 1 year after TAVI]
• Incidence of the combined endpoint of sudden death, symptomatic arrhythmias, or stroke) according to ECG abnormalities [Срок оценки: 1 year after TAVI]
• Incidence of the combined endpoint according to baseline ECG abnormality type [Срок оценки: 1 year after TAVI]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Institut universitaire de cardiologie et de pneumologie de Québec - UL — Québec

Публикации

• Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Fo PMID 26320108
• 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 C PMID 29084733
• 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. PMID 31564126
• 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 Wagon PMID 38043043
• 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 H PMID 30412709
• 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. PMID 38726722
• Muntane-Carol G, 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 Hernandez JM, Asmarats L, Pelletier-Beaumont E, Philippon F, Rodes-Cabau J. Arrhythmic burden in patients with new-onset persistent left bundle branch block a PMID 33083813
• 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. PMID 40738576

Идентификаторы

NCT: NCT07739316 · RECORDII- MP-10-2026-4441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗