Clinical trial NCT01624870: CoreValve Advance-II Study: Prospective International Post-market Study
Official title: CoreValve Advance-II Study: Best Practices Investigation of Patients Implanted With the Medtronic CoreValve Bioprosthesis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Valvular Heart Disease
Keywords: Aortic Valve Stenosis
Valvular Heart Disease
Transcatheter Aortic Valve Implantation
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aortic stenosis and at elevated surgical risk are eligible to be included in the study.

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.

Eligibility 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

Primary outcomes:
measure: New-onset Class I or II Indication for Permanent Pacemaker Implantation
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Combined Safety Endpoint
timeFrame: 30 days post procedure
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Trinec
country: Czechia
facility: Nemocnice Podlesi Trinec
city: Berlin
country: Germany
facility: Charite, Campus Mitte - Kardiologie Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Milan
country: Italy
facility: Istituto Clinico S. Ambrogio
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center Rotterdam
city: Leicester
country: United Kingdom
facility: Glenfield Hospital Leicester
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Anna Sonia Petronio, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.