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

Completed

• Conditions: Aortic Valve Stenosis; Valvular Heart Disease

• Registration Number: NCT01624870
• Lead Sponsor: Medtronic Bakken Research Center

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Primary Completion: 2013-10
• Study Completion: 2014-03
• Results First Submitted: 2016-09-06
• Results First Submitted QC: 2017-10-27
• Results First Posted: 2018-07-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
New-onset Class I or II Indication for Permanent Pacemaker Implantation	30 days post procedure	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.

Secondary Outcome Measures

Name	Time	Method
Combined Safety Endpoint	30 days post procedure	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.

Trial Locations

Locations (9)

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Nemocnice Podlesi Trinec; 🇨🇿 Trinec, Czechia

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Erasmus Medical Center Rotterdam; 🇳🇱 Rotterdam, Netherlands

Istituto Clinico S. Ambrogio; 🇮🇹 Milan, Italy

Charite, Campus Mitte - Kardiologie Berlin; 🇩🇪 Berlin, Germany

Glenfield Hospital Leicester; 🇬🇧 Leicester, United Kingdom