Overview

This trial is active, not recruiting.

Conditions aortic valve disease, aortic stenosis, rapid deployment valves
Sponsor Edwards Lifesciences
Start date July 2012
End date April 2016
Trial size 500 participants
Trial identifier NCT02338154, 2011-13

Summary

The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.

The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Operative Mortality. The procedure will be consid-ered a technical success if the subject leaves the Operating Room with the EDWARDS INTUITY valve in place.
time frame: The operative data that will be collected during the procedure.

Secondary Outcomes

Measure
Operative Adverse Events Post operative cardiac related events that resulted in medical or surgical intervention; all other serious adverse events occur-ring will be collected as well.
time frame: The operative data that will be collected during the procedure. Additional information will be collected at 30, 90 day and 1 and 2 year follow-up visits.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subject is 18 years or older 2. Subject presents with aortic stenosis or stenosis-based insuffi-ciency of an aortic valve requiring a planned replacement of the native aortic valve or previously implanted aortic prosthesis. 3. Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed. 4. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent. Exclusion Criteria: 1. History of active endocarditis within three months of scheduled surgery 2. Subject is diagnosed with pure aortic insufficiency 3. Aneurysm of the aortic root and/or ascending aorta

Additional Information

Official title Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.
Principal investigator Dr. Glauber, MD
Description Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses. Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2—5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left-ventricular ejection fraction, congestive heart fail-ure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms. Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents. In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aor-tic valve replacement. The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety. With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Valve system is well suited for smaller in-cisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.