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

Medtronic

Status: Completed

Conditions: Valvular Heart Disease; Aortic Valve Stenosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01624870

Advance-II

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

CoreValve aortic valve

Description:

Implantation of CoreValve aortic valve