CoreValve Advance-II Study: Prospective International Post-market Study

Study Overview
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Brief Summary
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The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.

Detailed Description
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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.

Official Title
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CoreValve Advance-II Study: Best Practices Investigation of Patients Implanted With the Medtronic CoreValve Bioprosthesis.

Conditions
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Aortic Valve Stenosis, Valvular Heart Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CoreValve aortic valve<br>Implantation of CoreValve aortic valve | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Stenosis, Valvular Heart Disease, Transcatheter Aortic Valve Implantation