Severe Aortic Stenosis
Conditions
Keywords
Advance, Medtronic CoreValve System, International, Interventional, Post Market Study
Brief summary
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a Real-World patient population.
Detailed description
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a Real-World patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.
Interventions
Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with severe aortic valve stenosis requiring treatment * Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context * Patient is above the minimum age as required by local regulations to be participating in a clinical study * The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form (Patient Informed Consent Form)
Exclusion criteria
* Currently participating in another trial * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac & Cerebrovascular Events (MACCE) | 30 days | MACCE is defined as a composite of: * All cause mortality * Myocardial Infarction (Q-wave and non-Q-wave) * Emergent cardiac surgery or percutaneous re-intervention * Stroke The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Device Success | up to 24 hours | Device Success is defined as a composite of: * Successful device delivery; * Stable device placement; * Intact retrieval of delivery catheter; * Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of \<15mmHg and ≤ 2 aortic regurgitation |
| Percentage of Participants With Procedural Success | up to 30 days | Procedural success, defined as device success with absence of in-hospital MACCE |
Countries
Belgium, Colombia, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Portugal, Switzerland, United Kingdom
Participant flow
Recruitment details
Start Recruitment March 2010 \> End Recruitment July 2011
Participants by arm
| Arm | Count |
|---|---|
| Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System. | 1,015 |
| Total | 1,015 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No implant attempted | 19 |
Baseline characteristics
| Characteristic | Medtronic CoreValve System |
|---|---|
| Age, Continuous | 81.1 years STANDARD_DEVIATION 6.4 |
| Sex: Female, Male Female | 514 Participants |
| Sex: Female, Male Male | 501 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 541 / 996 |
| serious Total, serious adverse events | 541 / 996 |
Outcome results
Primary
Major Adverse Cardiac & Cerebrovascular Events (MACCE)
MACCE is defined as a composite of: * All cause mortality * Myocardial Infarction (Q-wave and non-Q-wave) * Emergent cardiac surgery or percutaneous re-intervention * Stroke The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.
Time frame: 30 days
Population: All attempted population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic CoreValve System | Major Adverse Cardiac & Cerebrovascular Events (MACCE) | 92 Freedom from MACCE (%) @30days |
Secondary
Percentage of Participants With Device Success
Device Success is defined as a composite of: * Successful device delivery; * Stable device placement; * Intact retrieval of delivery catheter; * Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of \<15mmHg and ≤ 2 aortic regurgitation
Time frame: up to 24 hours
Population: All attempted population in which the separate variables related to device success (see outcome measure description) were analyzable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic CoreValve System | Percentage of Participants With Device Success | 79.4 percentage of participants |
Secondary
Percentage of Participants With Procedural Success
Procedural success, defined as device success with absence of in-hospital MACCE
Time frame: up to 30 days
Population: All attempted population in which the separate variables related to procedural success (see outcome measure description) were analyzable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic CoreValve System | Percentage of Participants With Procedural Success | 71.1 percentage of participants |