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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-03-31

Brief Summary

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

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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.

Conditions

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Aortic Valve Stenosis Valvular Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CoreValve aortic valve

Implantation of CoreValve aortic valve

No interventions assigned to this group

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No