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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01624870
First received: June 19, 2012
Last updated: June 28, 2014
Last verified: June 2014

June 19, 2012
June 28, 2014
October 2011
October 2013   (final data collection date for primary outcome measure)
Incidence of new-onset class I or II indication for Permanent Pacemaker Implantation [ Time Frame: 30 days post procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01624870 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
CoreValve Advance-II Study: Prospective International Post-market Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Aortic Valve Stenonis
  • Valvular Heart Disease
  • Transcatheter Aortic Valve Implantation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Germany,   Italy,   Netherlands,   United Kingdom
 
NCT01624870
Advance-II
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
Principal Investigator: Anna Sonia Petronio, M.D. Azienda Ospedaliero, Universitaria Pisana
Medtronic Bakken Research Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP