Trial · NCT01586910
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
NCT01586910, Not applicable, Active not recruiting, Medtronic Cardiovascular; results first posted 2019-09-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). Trials, record NCT01586910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01586910
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
- NCT number
- NCT01586910
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 1,746 participants, actual
- Lead sponsor
- Medtronic Cardiovascular
- Conditions
- Severe Aortic Stenosis
- Interventions
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- First posted
- 2012-04-27
- Last updated
- 2026-06-24
- Results first posted
- 2019-09-17
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group295
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability | Medtronic CoreValve® System TAVI | 12.6 | 95% Confidence Interval 10.2 to 15.3 | Percentage of Participants | |
| All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability | SAVR | 14.0 | 95% Confidence Interval 11.4 to 17.0 | Percentage of Participants | |
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Medtronic CoreValve® System TAVI | 30 days | 5.7 | percentage of participants | |
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | SAVR | 30 days | 7.3 | percentage of participants | |
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Medtronic CoreValve® System TAVI | 6 months | 9.5 | percentage of participants | |
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | SAVR | 6 months | 10.7 | percentage of participants | |
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Medtronic CoreValve® System TAVI | 12 months | 13.0 | percentage of participants | |
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | SAVR | 12 months | 13.0 | percentage of participants | |
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Medtronic CoreValve® System TAVI | 18 months | 15.6 | percentage of participants | |
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | SAVR | 18 months | 14.8 | percentage of participants |
1 to 10 of 295Source ClinicalTrials.gov
See all 295 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Medtronic CoreValve® System TAVI | 879 | |
| Overall Study | STARTED | SAVR | 867 | |
| Overall Study | COMPLETED | Medtronic CoreValve® System TAVI | 864 | |
| Overall Study | COMPLETED | SAVR | 796 | |
| Overall Study | NOT COMPLETED | Medtronic CoreValve® System TAVI | 15 | |
| Overall Study | NOT COMPLETED | SAVR | 71 |
Source ClinicalTrials.gov
Adverse events1,730
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Medtronic CoreValve® System TAVI | 80 | 864 | 84 |
| other | ANAEMIA | Blood and lymphatic system disorders | SAVR | 99 | 796 | 100 |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | Medtronic CoreValve® System TAVI | 70 | 864 | 71 |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | SAVR | 146 | 796 | 154 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Medtronic CoreValve® System TAVI | 133 | 864 | 140 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | SAVR | 188 | 796 | 198 |
| other | ATRIAL FIBRILLATION | Cardiac disorders | Medtronic CoreValve® System TAVI | 112 | 864 | 120 |
| other | ATRIAL FIBRILLATION | Cardiac disorders | SAVR | 230 | 796 | 239 |
| other | ATRIOVENTRICULAR BLOCK FIRST DEGREE | Cardiac disorders | Medtronic CoreValve® System TAVI | 80 | 864 | 82 |
| other | ATRIOVENTRICULAR BLOCK FIRST DEGREE | Cardiac disorders | SAVR | 67 | 796 | 68 |
1 to 10 of 1,730Source ClinicalTrials.gov
See all 1,730 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medtronic CoreValve® System TAVI | 98 | 864 |
| Total, all-cause mortality | SAVR | 80 | 796 |
| Total, other adverse events | Medtronic CoreValve® System TAVI | 803 | 864 |
| Total, other adverse events | SAVR | 754 | 796 |
| Total, serious adverse events | Medtronic CoreValve® System TAVI | 718 | 864 |
| Total, serious adverse events | SAVR | 694 | 796 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Medtronic CoreValve® System TAVI vs SAVR: deaths from any cause | Trial comparisons |
| Medtronic CoreValve® System TAVI vs SAVR: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01586910
GET https://conductscience.org/api/trials/v1/NCT01586910/registered?page=2