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

Aortic Valve Stenosis Clinical Trial

— Advance-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624870
• Other study ID #: Advance-II
• Status: Completed
• Start date: October 2011
• Est. completion date: March 2014

Study information

• Verified date: August 2018
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Czechia	Nemocnice Podlesi Trinec	Trinec
Germany	Charite, Campus Mitte - Kardiologie Berlin	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Heidelberg	Heidelberg
Italy	Istituto Clinico S. Ambrogio	Milan
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Netherlands	Erasmus Medical Center Rotterdam	Rotterdam
United Kingdom	Glenfield Hospital Leicester	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Belgium,  Czechia,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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