Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)

Обзор

Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.

Подробное описание

Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.

Вмешательства

• Поведенческое Standard care
  Patients discharged according to standard care
• Устройство PhysioMem PM 100 4G ambulatory monitoring system
  Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system

Первичные конечные точки

• Composite of all-cause death and rehospitalization for any reason [Срок оценки: 30 days]
• Clinically relevant arrhythmic event requiring a change in therapy [Срок оценки: 30 days]

Вторичные конечные точки (12)

• All-cause death [Срок оценки: 30 days]
• All-cause death [Срок оценки: 12 months]
• Unscheduled hospital readmission for any reason [Срок оценки: 30 days]
• Unscheduled hospital readmission for any reason [Срок оценки: 12 months]
• Cardiovascular death [Срок оценки: 30 days]
• Cardiovascular death [Срок оценки: 12 months]
• Hospital readmission due to cardiovascular cause [Срок оценки: 30 days]
• Hospital readmission due to cardiovascular cause [Срок оценки: 12 months]
• Implantation of a permanent pacemaker [Срок оценки: 30 days]
• Implantation of a permanent pacemaker [Срок оценки: 12 months]
• High-degree atrioventricular block (II or III) [Срок оценки: 30 days]
• De novo or recurrent atrial fibrillation requiring a change in therapy [Срок оценки: 30 days]

Критерии участия

Критерии включения

All inclusion criteria must be met

• Age ≥ 18 years and
• Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and
• Presence of at least one of the following conduction disorders and
• Pre-procedural basal conduction disorder (e.g., right/left bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec.
• De novo conduction disorder after TAVI (de novo bundle branch block) with QRS between 120-160 msec.
• Clinical stability at 24 hours post-procedure and
• Capacity to give informed consent.

Критерии исключения

No exclusion criteria must be met

• Immediate indication for permanent pacemaker following the procedure.
• Persistent complete atrioventricular block.
• QRS >160 msec and/or PR prolongation.
• Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge.
• Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system.
• Life expectancy < 12 months due to non-cardiovascular comorbidity.
• Refusal or inability to undergo outpatient follow-up.
• Pregnant or breastfeeding.

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

Другое

Центры проведения

Испания · 1 центр

• Hospital Unniversitari Vall d'Hebron — Barcelona

Публикации

• Szotek M, Druzbicki L, Sabatowski K, Amoroso GR, De Schouwer K, Matusik PT. Transcatheter Aortic Valve Implantation and Cardiac Conduction Abnormalities: Prevalence, Risk Factors and Management. J Clin Med. 2023 Sep 19;12(18):6056. doi: 10.3390/jcm12186056. PMID 37762995
• Mangieri A, Montalto C, Pagnesi M, Lanzillo G, Demir O, Testa L, Colombo A, Latib A. TAVI and Post Procedural Cardiac Conduction Abnormalities. Front Cardiovasc Med. 2018 Jul 3;5:85. doi: 10.3389/fcvm.2018.00085. eCollection 2018. PMID 30018969
• Tsoi M, Tandon K, Zimetbaum PJ, Frishman WH. Conduction Disturbances and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: Predictors and Prevention. Cardiol Rev. 2022 Jul-Aug 01;30(4):179-187. doi: 10.1097/CRD.0000000000000398. Epub 2021 Jun 14. PMID 34132653
• van Gils L, Baart S, Kroon H, Rahhab Z, El Faquir N, Rodriguez Olivares R, Aga Y, Maugenest AM, Theuns DA, Boersma E, Szili Torok T, De Jaegere PP, Van Mieghem NM. Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study. Europace. 2018 Dec 1;20(12):1981-1988. doi: 10.1093/europace/euy074. PMID 29688322
• Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, Garcia-Garcia H, Schultz C, van Domburg R, van Es GA, van Geuns R, de Jaegere P, Serruys PW. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation. EuroIntervention. 2010 Sep;6(4):475-84. doi: 10.4244/EIJ30V6I4A80. PMID 20884435
• 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. PMID 32005676

Идентификаторы

NCT: NCT07456280 · IMPROVE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗