CoreValve Advance-II Study: Prospective International Post-market Study (Advance-II)
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ClinicalTrials.gov Identifier: NCT01624870
Recruitment Status :
First Posted : June 21, 2012
Last Update Posted : October 27, 2015
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis. The purpose of the study is to characterize best practices for CoreValve implantation in an effort to evolve implantation guidelines.
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Ages Eligible for Study:
21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with aortic stenosis and at elevated surgical risk are eligible to be included in the study.
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.
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)