What is medtronic corevalve clinical trial

QoL summary score change from baseline using the following measures: Kansas City Cardiomyopathy Questionnaire KCCQ : Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life.

Scores are transformed to a range of , in which higher scores reflect better health status. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state. Using the following measures: - Transvalvular Mean Gradient. Eligibility Criteria. Inclusion Criteria: Extreme Risk Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement.

The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.

The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the intended treatment. High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure. Untreated clinically significant coronary artery disease requiring revascularization. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.

Need for emergency surgery for any reason. Active Gastrointestinal GI bleeding within the past 3 months. Subject refuses a blood transfusion. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.

Currently participating in an investigational drug or another device trial. Symptomatic carotid or vertebral artery disease. Subject has been offered surgical aortic valve replacement but declined.

Pre-existing prosthetic heart valve any position. Moderate to severe mitral stenosis. Hypertrophic obstructive cardiomyopathy. New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation. Severe basal septal hypertrophy with an outflow gradient. Congenital bicuspid or unicuspid valve verified by echocardiography. Sinus of valsalva anatomy that would prevent adequate coronary perfusion.

Vascular - Transarterial access not able to accommodate an 18Fr sheath. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Additional Information: Related Info. J Am Heart Assoc. Epub Sep Circ Cardiovasc Interv. Epub Nov Am J Cardiol.

Epub Jun Epub Oct JAMA Cardiol. Circ Cardiovasc Interv. J Am Coll Cardiol. N Engl J Med. Epub Mar Haussig S, Linke A. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients.

National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Severe Aortic Stenosis. Not Applicable. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :.

Estimated Study Completion Date :. New Haven, Connecticut, United States, Washington, District of Columbia, United States, Philadelphia, Pennsylvania, United States, Wormleysburg, Pennsylvania, United States, The enrollment phase of the study is estimated to take approximately months.

As each implanted subject is to be followed up to 5 years, the estimated study duration is approximately months, excluding the time required for preparing the final report. Acute episode of focal or global neurological deficit with at least 2 of the following:. No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist.

Confirmation of the diagnosis by at least 1 of the following:. Percentage of patients with Device Success defined as:. Bleeding in a critical organs, such as intracranial, intraspinal,. Access-related vascular injury dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR.

Distal embolization noncerebral from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR. The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR.

Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. Save this study. Warning You have reached the maximum number of saved studies Clinical Study The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details.

Results First Posted : December 12, Last Update Posted : November 26, Study Description. The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement TAVR system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.

Detailed Description:. FDA Resources.