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The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoreValve aortic valve | Implantation of CoreValve aortic valve |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with aortic stenosis and at elevated surgical risk are eligible to be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Sonia Petronio, M.D. | Azienda Ospedaliero, Universitaria Pisana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium | |||
| Nemocnice Podlesi Trinec |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25999108 | Derived | Petronio AS, Sinning JM, Van Mieghem N, Zucchelli G, Nickenig G, Bekeredjian R, Bosmans J, Bedogni F, Branny M, Stangl K, Kovac J, Schiltgen M, Kraus S, de Jaegere P. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study. JACC Cardiovasc Interv. 2015 May;8(6):837-846. doi: 10.1016/j.jcin.2015.02.005. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled | All subjects who enrolled in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled | All subjects enrolled in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | the populations used for this parameter are sub-population of the 194 implanted subjects for whom data of implant depth was available | Posted | Number | 95% Confidence Interval | Percentage of subjects | 30 days post procedure |
|
Adverse event data were collected up to 6 months post-implant procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Implanted | All subjects who were implanted with the CoreValve device. All subjects in whom the procedure was attempted were implanted with the CoreVave device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Permanent Pacemaker Implantation | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke-TIA | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maarten Hollander | Medtronic Bakken Research Center | +31620534428 | maarten.hollander@medtronic.com |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| Třinec |
| 73961 |
| Czechia |
| Charite, Campus Mitte - Kardiologie Berlin | Berlin | 10117 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Istituto Clinico S. Ambrogio | Milan | 20149 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56100 | Italy |
| Erasmus Medical Center Rotterdam | Rotterdam | 3015 CE | Netherlands |
| Glenfield Hospital Leicester | Leicester | Le3 9 QP | United Kingdom |
| Lost to follow up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | CoreValve Implant Depth >6mm | Enrolled subjects with a CoreVavle device at an implant depth of >6mm |
|
|
| 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. | All implanted | Posted | Number | Percentage of subjects | 30 days post procedure |
|
|
|
| 17 |
| 194 |
| 113 |
| 194 |
| 151 |
| 194 |
| Stroke-TIA | Vascular disorders | Systematic Assessment |
|
| Bleeding | Vascular disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Coronary obstruction | Vascular disorders | Systematic Assessment |
|
| Vascular access site and access-related complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Valve-related dysfunction requiring repeat procedure | Surgical and medical procedures | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Bleeding Event | Vascular disorders | Systematic Assessment |
|
| Permanent Pacemaker Implantation | Surgical and medical procedures | Systematic Assessment |
|
| Re-intervention | Surgical and medical procedures | Systematic Assessment |
|
| Vascular access site and access-related complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other Adverse Event | General disorders | Systematic Assessment | Any other reported adverse event not associated with the use of the study device were collected without a specific adverse event term. |
|
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