Trial · NCT01586910
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability | 24 months | All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline. |
| Secondary | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) |
| Secondary | Percentage of Participants With Individual MACCE Components | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) |
| Secondary | Percentage of Participants With Major Adverse Events (MAE) | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis. |
| Secondary | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | |
| Secondary | Change in NYHA Class From Baseline | Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. |
| Secondary | Change in Distance Walked During 6-minute Walk Test (6MWT) | From baseline to 30 days, baseline to 12 months, and baseline to 24 months | Change in distance walked during 6MWT from baseline |
| Secondary | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 12 and 24 months | |
| Secondary | Quality of Life (QoL) Change From Baseline | Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete. | QoL summary score change from baseline using the following measures: * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state. |
| Secondary | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete | Using the following measure: -Transvalvular mean gradient |
| Secondary | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete | Using the following measure: -Effective Orifice Area (cm\^2) |
| Secondary | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete | Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular) |
| Secondary | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | |
| Secondary | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete | |
| Secondary | Percentage of Participants With Stroke and TIAs | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | Strokes (of any severity) and Transient Ischemic Attacks (TIAs) |
| Secondary | Peri-procedural Neurological Injury | discharge or 7 days post index procedure (whichever occurred first) | Neurological injury (stroke, TIA, or encephalopathy) |
| Secondary | Index Procedure Related Major Adverse Events (MAEs) | Procedure through 30 day visit | Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure. |
| Secondary | Length of Index Procedure Hospital Stay | Number of days from admission to discharge (expected average of 7 days) | |
| Secondary | Presence of Atrial Fibrillation | post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | |
| Secondary | Device Success (Medtronic CoreValve® System Subjects Only) | Number of days from admission to discharge (expected average of 7 days) | * Absence of procedural mortality * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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