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

This study is currently recruiting participants.
Verified June 2012 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01624870
First received: June 19, 2012
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Incidence of new-onset class I or II indication for Permanent Pacemaker Implantation [ Time Frame: 30 days post procedure ] [ Designated as safety issue: No ]

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

    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)


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624870

Contacts
Contact: Rijk de Jong, MSc +31 (0) 43 3566613 rijk.de.jong@medtronic.com
Contact: Maarten Hollander, MSc +31 (0) 43 3566864 maarten.hollander@medtronic.com

Locations
Belgium
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Principal Investigator: Johan Bosmans, M.D.            
Czech Republic
Nemocnice Podlesi Trinec Not yet recruiting
Trinec, Czech Republic, 73961
Principal Investigator: Marian Branny, M.D.            
Germany
Charite, Campus Mitte - Kardiologie Berlin Recruiting
Berlin, Germany, 10117
Principal Investigator: Karl Stangl, M.D.            
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53127
Principal Investigator: Georg Nickenig, M.D.            
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Raffi Bekeredijan, M.D.            
Italy
Istituto Clinico S. Ambrogio Not yet recruiting
Milan, Italy, 20149
Principal Investigator: Francesco Bedogni, M.D.            
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy, 56100
Principal Investigator: Anna Sonia Petronio, M.D.            
Netherlands
Erasmus Medical Center Rotterdam Recruiting
Rotterdam, Netherlands, 3015 CE
Principal Investigator: Peter de Jaegere, M.D.            
United Kingdom
Glenfield Hospital Leicester Not yet recruiting
Leicester, United Kingdom, Le3 9 QP
Principal Investigator: Jan Kovac, M.D.            
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Anna Sonia Petronio, M.D. Azienda Ospedaliero, Universitaria Pisana
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01624870     History of Changes
Other Study ID Numbers: Advance-II
Study First Received: June 19, 2012
Last Updated: June 20, 2012
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Germany: Ethics Commission
Belgium: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Independent Ethics Committee
Czech Republic: Ethics Committee

Keywords provided by Medtronic Bakken Research Center:
Aortic Valve Stenonis
Valvular Heart Disease
Transcatheter Aortic Valve Implantation

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013