Feature | November 01, 2013

Clinical Trial Finds CoreValve Reduces Rate of Death, Stroke in Patients With Aortic Stenosis

Results of the CoreValve Extreme Risk trial presented at TCT 2013

heart valve repair hybrid or cath lab structural heart tct medtronic corevalve
November 1, 2013 — In a clinical trial, the Medtronic Corevalve self-expanding transcatheter aortic valve met the key performance objective of reducing death and stroke in patients with severe aortic stenosis at “extreme risk” for surgery. Results of the CoreValve Extreme Risk trial were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013) in San Francisco.
 
The CoreValve Extreme Risk trial was a prospective, multicenter, controlled, non-randomized, single-arm investigation evaluating the safety and efficacy of the transfemorally implanted CoreValve self-expanding transcatheter heart valve. The trial was conducted in 487 patients with symptomatic, severe aortic stenosis. 
 
All patients were deemed to be at extreme risk for surgical aortic valve replacement, and were thus treated with the Corevalve device. The primary endpoint was a composite of all-cause mortality or major stroke rate at 12 months; the Kaplan-Meier determined event rate was compared with a pre-specified objective performance goal (OPG). 
 
Of the 487 patients enrolled in the study, 471 had an attempted implantation and were designated as the primary "as treated" analysis population. Patients were elderly (83.1 years), and were severely symptomatic (NYHA class III or IV, 91.9 percent). The Society for Thoracic Surgery predicted risk of mortality was 10.3 percent ± 5.6 percent and was > 15 percent in 17.6 percent of patients. 
 
At 12 months, the composite rate of death or major stroke was 25.5 percent, significantly below the 95 percent confidence interval of the performance goal, which was set at 43 percent. While moderate paravalvular leak was observed in 11 percent of patients at one month, 80 percent of patients with moderate paravalvular (PV) leak at one month who survived to one year experienced a reduction in PV leak over time.
 
“The CoreValve Extreme Risk study achieved its primary endpoint of a reduction in all cause mortality or major stroke at one year compared to a rigorously defined OPG,” said Jeffrey Popma, M.D., lead investigator, director, Interventional Cardiology, Beth Israel Deaconess Medical Center.
 
Medtronic has three FDA IDE trials evaluating the Corevalve for high-risk and extreme-risk surgical patients and in patients at intermediate risk for open-heart aortic valve replacement (SURTAVI Trial).
 
For more information: www.crf.org, www.medtronic.com

Related Content

ultrasound-activated microbubbles, heart attack, pig model, NIBIB, human clinical trials

An ultrasound-stimulated microbubble burrows through a fibrin clot (green) allowing penetration of the surrounding fluid into the clot (yellow). Image courtesy of Christopher Acconci and David Goertz, University of Toronto.

News | Ultrasound Imaging| February 11, 2016
Researchers funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) used ultrasound-activated...
Fred Hoiberg, Chicago Bulls coach, On-X aortic heart valve, education campaign

Fred Hoiberg, head coach of the NBA Chicago Bulls, is launching a new campaign to help people with heart valve problems on www.heartvalvesurgery.com. Coach Hoiberg, pictured here with his family, wanted a single, life-long solution to his aortic heart valve problem, and received an On-X aortic mechanical valve from On-X Life Technologies Inc. in April 2015.

News | Heart Valve Repair| February 10, 2016
February 10, 2016 — Fred Hoiberg, head coach of the National Basketball Assocation’s (NBA) Chicago Bulls, is launchin

Image courtesy of Boston Scientific

Feature | Business| February 10, 2016 | Dave Fornell
After five years of almost constant lobbying efforts and numerous attempts by the U.S.
CeloNova, COBRA REDUCE trial, first patient enrolled, Cobra PzF coronary stent
News | Stents| February 10, 2016
CeloNova BioSciences Inc. announced this week that the first patient has been enrolled in its COBRA REDUCE trial. The...
HeartWare, terminated acquisition, Valtech Cardio
News | Structural Heart| February 10, 2016
February 10, 2016 — HeartWare International Inc. and Valtech Cardio Ltd.
Valtech Cardioband, reimbursement, Germany, mitral regurgitation in heart failure
News | Heart Valve Repair| February 09, 2016
Valtech Cardio Ltd. announced that it has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
Watchman, left atrial appendage closure, LAA occluder
Technology | Left Atrial Appendage (LAA) Occluders| February 09, 2016
February 9, 2016 — Boston Scientific Corp.
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
Stereotaxis, Philips, collaboration, Niobe ES remote magnetic navigation system, Allura Xper FD10 cardiovascular X-ray

Niobe ES image courtesy of Stereotaxis Inc.

Technology | Cath Lab| February 04, 2016
February 4, 2016 — Stereotaxis and Philips have signed an addendum pursuant to their existing Development and Coopera
Overlay Init