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

Medtronic Cardiac Rhythm and Heart Failure200 enrolled

Overview

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

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

Enrollment

200

Conditions

Aortic Valve Stenosis Valvular Heart Disease

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (9)

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Nemocnice Podlesi Trinec

Třinec, Czechia

Charite, Campus Mitte - Kardiologie Berlin

Berlin, Germany

Universitätsklinikum Bonn

Bonn, Germany

Outcomes

Primary Outcomes

New-onset Class I or II Indication for Permanent Pacemaker Implantation

The Kaplan-Meier estimate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or \>6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines.

Time frame: 30 days post procedure

Secondary Outcomes

Combined Safety Endpoint

The Kaplan-Meier estimate of all-cause mortality, major stroke, life threatening (or disabling) bleeding, acute Kidney Injury - Stage 3 (including renal denervation therapy), peri-procedural myocardial infarction or repeat procedure for valve related dysfunction (surgical or interventional). A Kaplan Meier assessment was used to determine the composite rate.

Time frame: 30 days post procedure

Data from ClinicalTrials.gov

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