Brief Title
CoreValve Advance-II Study: Prospective International Post-market Study
Official Title
CoreValve Advance-II Study: Best Practices Investigation of Patients Implanted With the Medtronic CoreValve Bioprosthesis.
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.
Study Type
Observational
Primary Outcome
New-onset Class I or II Indication for Permanent Pacemaker Implantation
Secondary Outcome
Combined Safety Endpoint
Condition
Aortic Valve Stenosis
Study Arms / Comparison Groups
CoreValve aortic valve
Description: Implantation of CoreValve aortic valve
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
200
Start Date
October 2011
Completion Date
March 2014
Primary Completion Date
October 2013
Eligibility Criteria
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
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Anna Sonia Petronio, M.D., ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT01624870
Organization ID
Advance-II
Responsible Party
Sponsor
Study Sponsor
Medtronic Bakken Research Center
Study Sponsor
Anna Sonia Petronio, M.D., Principal Investigator, Azienda Ospedaliero, Universitaria Pisana
Verification Date
August 2018