Trial · NCT01586910
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability | 24 months | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | Percentage of Participants | MEDIAN |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | percentage of participants | NUMBER |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | percentage of participants | NUMBER |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | percentage of participants | NUMBER |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | percentage of participants | NUMBER |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | units on a scale | MEAN |
| 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 | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | meters | MEAN |
| SECONDARY | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 12 and 24 months | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | ratio | MEAN |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | units on a scale | MEAN |
| 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 | Participant Population= Consisted of all randomized subjects with a valve implanted | mmHg | MEAN |
| 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 | Participant Population= Consisted of all randomized subjects with a valve implanted | cm^2 | MEAN |
| 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 | Participant Population= Consisted of all randomized subjects with a valve implanted | Percentage of participants | NUMBER |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | percentage of particpants | NUMBER |
| 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 | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | percentage of participants | NUMBER |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Peri-procedural Neurological Injury | discharge or 7 days post index procedure (whichever occurred first) | Participant Population= Consisted of all randomized subjects with an index procedure | percentage of participants | NUMBER |
| SECONDARY | Index Procedure Related Major Adverse Events (MAEs) | Procedure through 30 day visit | Participant Population= Consisted of all randomized subjects with an index procedure | percentage of participants | NUMBER |
| SECONDARY | Length of Index Procedure Hospital Stay | Number of days from admission to discharge (expected average of 7 days) | Participant Population= Consisted of all randomized subjects with an index procedure | days | MEAN |
| 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. | Participant Population= Consisted of all randomized subjects with an attempted implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Device Success (Medtronic CoreValve® System Subjects Only) | Number of days from admission to discharge (expected average of 7 days) | Participant Population =Consisted of all randomized subjects with a TAVR index procedure who were evaluable for device success. | percentage of participants | NUMBER |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01586910/outcomes