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

This study has been completed.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center ) Identifier:
First received: June 19, 2012
Last updated: October 26, 2015
Last verified: October 2015
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.

Aortic Valve Stenonis
Valvular Heart Disease
Transcatheter Aortic Valve Implantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CoreValve Advance-II Study: Best Practices Investigation of Patients Implanted With the Medtronic CoreValve Bioprosthesis.

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Incidence of new-onset class I or II indication for Permanent Pacemaker Implantation [ Time Frame: 30 days post procedure ]

Secondary Outcome Measures:
  • Combined safety endpoint [ Time Frame: 30 days post procedure ]

    the combined safety endpoint is defined as a composite rate of:

    • all cause mortality
    • major stroke
    • Life threatening (or disabling) bleeding
    • Acute Kidney Injury - Stage 3 (including renale denervation therapy)
    • Peri-Procedural MI
    • Repeat procedure for valve-related dysfunction (surgical or interventional therapy)

Enrollment: 200
Study Start Date: October 2011
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis. The purpose of the study is to characterize best practices for CoreValve implantation in an effort to evolve implantation guidelines.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with aortic stenosis and at elevated surgical risk are eligible to be included in the study.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01624870

Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Czech Republic
Nemocnice Podlesi Trinec
Trinec, Czech Republic, 73961
Charite, Campus Mitte - Kardiologie Berlin
Berlin, Germany, 10117
Universitätsklinikum Bonn
Bonn, Germany, 53127
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Istituto Clinico S. Ambrogio
Milan, Italy, 20149
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56100
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands, 3015 CE
United Kingdom
Glenfield Hospital Leicester
Leicester, United Kingdom, Le3 9 QP
Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: Anna Sonia Petronio, M.D. Azienda Ospedaliero, Universitaria Pisana
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center Identifier: NCT01624870     History of Changes
Other Study ID Numbers: Advance-II
Study First Received: June 19, 2012
Last Updated: October 26, 2015

Keywords provided by Medtronic Cardiovascular:
Aortic Valve Stenonis
Valvular Heart Disease
Transcatheter Aortic Valve Implantation

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases processed this record on May 25, 2017