- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01651052
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kraków, Polonia, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawła II
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Warsaw, Polonia, 04-628
- Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18 years or older
- Require replacement of aortic valve
- Signed informed consent
- Willing to return to study site for follow-up visits
Exclusion Criteria:
- Active endocarditis/myocarditis (< 3 months)
- Myocardial infarction (< 30 days)
- Renal insufficiency/ End-stage renal disease
- Life expectancy (< 1 year)
- Requires multiple valve replacement/repair
- Requiring emergent aortic valve surgery
- Pregnant or lactating
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
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Implant of an aortic valve, Model 11000
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Numero di eventi avversi precoci diviso per il numero di soggetti (espresso in percentuale)
Lasso di tempo: Eventi verificatisi entro 30 giorni dalla procedura
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Numero di eventi avversi precoci verificatisi entro 30 giorni dalla procedura diviso per il numero di soggetti arruolati moltiplicato per 100
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Eventi verificatisi entro 30 giorni dalla procedura
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Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Lasso di tempo: Events occurring >= 31 days and up through 5 years post-implant
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Number of late events divided by the total number of late patient years x 100.
Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
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Events occurring >= 31 days and up through 5 years post-implant
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Subject's Average Mean Gradient Measurements
Lasso di tempo: Baseline through 5-Year (at each scheduled follow-up visit)
|
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Gradients are evaluated by echocardiography over time.
Mean gradient values depend on the size and type of valve.
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Baseline through 5-Year (at each scheduled follow-up visit)
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Subject's Average Effective Orifice Area Measurements
Lasso di tempo: Baseline through 5-Year (at each scheduled follow-up visit)
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Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve.
Effective orifice area is evaluated by echocardiography over time.
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Baseline through 5-Year (at each scheduled follow-up visit)
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Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Lasso di tempo: 3-6 Months and 1 through 5 Years compared to baseline
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The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. |
3-6 Months and 1 through 5 Years compared to baseline
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Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Lasso di tempo: Baseline and one year follow-up
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The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. |
Baseline and one year follow-up
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Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Lasso di tempo: Baseline and 1 Year
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The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000.
A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
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Baseline and 1 Year
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Subject's Average White Blood Cell Count
Lasso di tempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Red Blood Cells Count
Lasso di tempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Hemoglobin Count
Lasso di tempo: Baseline, 3-6 months, and 1 through 5 years
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Laboratory Analysis of Hemoglobin Count on blood drawn from subjects.
Hemoglobin is an oxygen-carrying protein in red blood cells.
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Baseline, 3-6 months, and 1 through 5 years
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Subject's Average Hematocrit Percentage
Lasso di tempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects.
Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Platelet Count
Lasso di tempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Plasma Free Hemoglobin
Lasso di tempo: Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects.
This blood test measures the level of free hemoglobin in the liquid part of the blood (the serum).
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Serum Creatinine
Lasso di tempo: Baseline
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Laboratory Analysis of Serum Creatinine on blood drawn from subjects.
Creatinine blood test is a test that measures kidney function.
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Baseline
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Subject's Average International Normalized Ratio
Lasso di tempo: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. |
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Subject's Average Partial Thromboplastin Time
Lasso di tempo: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects.
PTT is a blood test that looks at how long it takes for the blood to clot.
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Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Subject's Average Prothrombin Time
Lasso di tempo: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects.
The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.
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Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jerzy Sadowski, MD, John Paul II Hospital
- Investigatore principale: Jacek Rozanski, MD, The Cardinal Stefan Wyszynski Institute of Cardiology
Pubblicazioni e link utili
Pubblicazioni generali
- De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.
- Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapor M, Wozniak S, Rozanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol. 2018;76(3):618-624. doi: 10.5603/KP.a2017.0262. Epub 2018 Jan 3.
- Sadowski J, Bartus K, Kapelak B, Chung A, Stapor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317-22. doi: 10.5603/KP.a2014.0214. Epub 2014 Nov 5.
- Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, Sadowski J, Filip G, Kusmierczyk M, Kapelak B. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):434-441. doi: 10.1093/ejcts/ezaa311.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Ischemia miocardica
- Malattie cardiache
- Malattia cardiovascolare
- Malattie vascolari
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattie delle valvole cardiache
- Ostruzione del deflusso ventricolare
- Malattia coronarica
- Disfunsione dell'arteria coronaria
- Stenosi della valvola aortica
- Insufficienza della valvola aortica
- Malattia della valvola aortica
Altri numeri di identificazione dello studio
- 2010-03
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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