N/A Completed N=200

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

Aortic Valve Stenosis · Heart Failure

Source: ClinicalTrials.gov NCT01624870 ↗

Enrolled (actual)

200

Serious AEs

58.3%

Results posted

Jul 2018

Primary outcomePrimary: New-onset Class I or II Indication for Permanent Pacemaker Implantation — 13.3; 21.4 Percentage of subjects

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY New-onset Class I or II Indication for Permanent Pacemaker Implantation	13.3; 21.4	—
SECONDARY Combined Safety Endpoint	6.7	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01624870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.