Aortic Valve Stenosis, Valvular Heart Disease
Conditions
Keywords
Aortic Valve Stenosis, Valvular Heart Disease, Transcatheter Aortic Valve Implantation
Brief summary
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
Detailed description
The purpose of the study was to investigate the rate of conduction disturbances after trans-catheter aortic valve implantation of the Medtronic CoreValve device, aiming to characterize best practices. The investigators did not assign study specific interventions to the subjects in the study.
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fulfilling the criteria of labeling indications of the CoreValve System; * Patient is above the minimum age as required by local regulations to be participating in a clinical trial regardless of gender and race; * Provided Signed Informed Consent or Data Release Form.
Exclusion criteria
* Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator); * Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines; * Persistent or permanent atrial fibrillation (except paroxysmal AF); * Participation in another drug or device study that would jeopardize the appropriate analysis of endpoints of this study. * 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 |
|---|---|---|
| New-onset Class I or II Indication for Permanent Pacemaker Implantation | 30 days post procedure | The Kaplan-Meier estimate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or \>6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Safety Endpoint | 30 days post procedure | The Kaplan-Meier estimate of all-cause mortality, major stroke, life threatening (or disabling) bleeding, acute Kidney Injury - Stage 3 (including renal denervation therapy), peri-procedural myocardial infarction or repeat procedure for valve related dysfunction (surgical or interventional). A Kaplan Meier assessment was used to determine the composite rate. |
Countries
Belgium, Czechia, Germany, Italy, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled All subjects enrolled in the study | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | CoreValve not implanted | 6 |
| Overall Study | Death | 19 |
| Overall Study | Lost to follow up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Enrolled |
|---|---|
| Age, Continuous | 80.2 years STANDARD_DEVIATION 6.7 |
| Region of Enrollment Belgium | 19 participants |
| Region of Enrollment Czech Republic | 12 participants |
| Region of Enrollment Germany | 70 participants |
| Region of Enrollment Italy | 51 participants |
| Region of Enrollment Netherlands | 40 participants |
| Region of Enrollment United Kingdom | 8 participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 194 |
| other Total, other adverse events | 151 / 194 |
| serious Total, serious adverse events | 113 / 194 |
Outcome results
Primary
New-onset Class I or II Indication for Permanent Pacemaker Implantation
The Kaplan-Meier estimate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or \>6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines.
Time frame: 30 days post procedure
Population: the populations used for this parameter are sub-population of the 194 implanted subjects for whom data of implant depth was available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoreValve Implant Depth ≤6mm | New-onset Class I or II Indication for Permanent Pacemaker Implantation | 13.3 Percentage of subjects |
| CoreValve Implant Depth >6mm | New-onset Class I or II Indication for Permanent Pacemaker Implantation | 21.4 Percentage of subjects |
Secondary
Combined Safety Endpoint
The Kaplan-Meier estimate of all-cause mortality, major stroke, life threatening (or disabling) bleeding, acute Kidney Injury - Stage 3 (including renal denervation therapy), peri-procedural myocardial infarction or repeat procedure for valve related dysfunction (surgical or interventional). A Kaplan Meier assessment was used to determine the composite rate.
Time frame: 30 days post procedure
Population: All implanted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoreValve Implant Depth ≤6mm | Combined Safety Endpoint | 6.7 Percentage of subjects |