CoreValve Advance-II Study: Prospective… | Clinical Trial

Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Valvular Heart Disease Ventricular Outflow Obstruction

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

New-onset Class I or II Indication for Permanent Pacemaker Implantation

Time frame: 30 days post procedure

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.

Secondary outcomes

Combined Safety Endpoint

Time frame: 30 days post procedure

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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

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

Acronym: Advance-II

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: Jun 21, 2012
Registry last updated: Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed