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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01624870
Other study ID # Advance-II
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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