Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early discharge (24 hours post-TAVI) | Experimental | Patients will be discharged from the hospital 24 hours post-TAVI with PhysioMem PM 100 4G ambulatory monitoring system. |
|
| Discharge according Standard Care | Active Comparator | Patients will be discharged from the hospital according standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Behavioral | Patients discharged according to standard care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause death and rehospitalization for any reason | Proportion of patients with:
| 30 days |
| Clinically relevant arrhythmic event requiring a change in therapy | Proportion of patients with clinically relevant arrhythmic event requiring a change in therapy, defined as the occurrence of any of the following:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | Incidence of all-cause death | 30 days |
| All-cause death | Incidence of all-cause death | 12 months |
Not provided
Inclusion Criteria:
All inclusion criteria must be met
Exclusion Criteria:
No exclusion criteria must be met
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno GarcÃa del Blanco, MD, PhD | Contact | 00342746155 | bruno.garcia@vallhebron.cat |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Unniversitari Vall d'Hebron | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37762995 | Background | 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. | |
| 30018969 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PhysioMem PM 100 4G ambulatory monitoring system | Device | Patients discharged with PhysioMem PM 100 4G ambulatory monitoring system |
|
| Unscheduled hospital readmission for any reason | Incidence of unscheduled hospital readmission for any reason | 30 days |
| Unscheduled hospital readmission for any reason | Incidence of unscheduled hospital readmission for any reason | 12 months |
| Cardiovascular death | Incidence of cardiovascular death | 30 days |
| Cardiovascular death | Incidence of cardiovascular death | 12 months |
| Hospital readmission due to cardiovascular cause | Incidence of Hospital readmission due to cardiovascular cause | 30 days |
| Hospital readmission due to cardiovascular cause | Incidence of Hospital readmission due to cardiovascular cause | 12 months |
| Implantation of a permanent pacemaker | Incidence of Implantation of a permanent pacemaker | 30 days |
| Implantation of a permanent pacemaker | Incidence of Implantation of a permanent pacemaker | 12 months |
| High-degree atrioventricular block (II or III) | Incidence of High-degree atrioventricular block (II or III) | 30 days |
| De novo or recurrent atrial fibrillation requiring a change in therapy | Incidence of De novo or recurrent atrial fibrillation requiring a change in therapy | 30 days |
| Time to pacemaker implantation or therapeutic change due to arrhythmia | Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia | 30 days |
| Time to pacemaker implantation or therapeutic change due to arrhythmia | Incidence of Time to pacemaker implantation or therapeutic change due to arrhythmia | 12 months |
| Resolution vs persistence of conduction disorders | Incidence of Resolution vs persistence of conduction disorders detected in the first 72 hours after TAVI implantation | 72 hours |
| QRS evolution: transient, persistent, or normalisation | Incidence of QRS evolution: transient, persistent, or normalisation | 30 days |
| Remote monitoring | Percentage of time monitored correctly | 30 days |
| hospital length to of stay from TAVI to discharge | Duration of hospitalization post-TAVI procedure | At discharge |
| Direct cost associated with stay and readmissions | Evaluation of Direct cost associated with hospital stay and readmissions | 12 Months |
| Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ) | Quality of life assessed using (KCCQ)assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire developed to assess HRQoL (Health-Related Quality of Life) in patients with congestive heart failure. The KCCQ consists of five domains: physical limitation, symptoms (frequency, severity, and recent change over time), QoL (Quality of Life), social interference, and self-efficacy. The total score ranges from 0 to 100, and higher scores reflect better health status. | 30 days |
| Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ) | Quality of life assessed using (KCCQ)assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire developed to assess HRQoL (Health-Related Quality of Life) in patients with congestive heart failure. The KCCQ consists of five domains: physical limitation, symptoms (frequency, severity, and recent change over time), QoL (Quality of Life), social interference, and self-efficacy. The total score ranges from 0 to 100, and higher scores reflect better health status. | 12 Months |
| 34132653 | Background | 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. |
| 29688322 | Background | 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. |
| 20884435 | Background | 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. |
| 32005676 | Background | 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. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided