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

CoreValve Advance-II Study: Best Practices Investigation of Patients Implanted With the Medtronic CoreValve Bioprosthesis.

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Valvular Heart Disease

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
• Czechia
  • Trinec, Czechia, 73961
    • Nemocnice Podlesi Trinec
• Germany
  • Berlin, Germany, 10117
    • Charite, Campus Mitte - Kardiologie Berlin
  • Bonn, Germany, 53127
    • Universitatsklinikum Bonn
  • Heidelberg, Germany, 69120
    • UniversitatsKlinikum Heidelberg
• Italy
  • Milan, Italy, 20149
    • Istituto Clinico S. Ambrogio
  • Pisa, Italy, 56100
    • Azienda Ospedaliero Universitaria Pisana
• Netherlands
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medical Center Rotterdam
• United Kingdom
  • Leicester, United Kingdom, Le3 9 QP
    • Glenfield Hospital Leicester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic stenosis and at elevated surgical risk are eligible to be included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CoreValve aortic valve; Implantation of CoreValve aortic valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post procedure

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Anna Sonia Petronio, M.D., Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

General Publications

• Petronio AS, Sinning JM, Van Mieghem N, Zucchelli G, Nickenig G, Bekeredjian R, Bosmans J, Bedogni F, Branny M, Stangl K, Kovac J, Schiltgen M, Kraus S, de Jaegere P. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study. JACC Cardiovasc Interv. 2015 May;8(6):837-846. doi: 10.1016/j.jcin.2015.02.005.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; Valvular Heart Disease; Transcatheter Aortic Valve Implantation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Diseases; Aortic Valve Stenosis; Heart Valve Diseases
• Other Study ID Numbers: Advance-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO