News | Heart Valve Technology | March 07, 2016

Medtronic Enrolls First Patients in Evolut R FORWARD Clinical Study

International trial designed to confirm the results achieved in the Evolut R CE Study of the CoreValve Evolut R Transcatheter aortic valve implantation system

Medtronic, Corevalve, Evolut R FORWARD Clinical Study, first patients enrolled

March 7, 2016 — Medtronic plc announced the first patients enrolled in the Evolut R FORWARD Clinical Study to evaluate performance outcomes using the CoreValve Evolut R System in everyday clinical practice.

A next-generation, recapturable and repositionable transcatheter aortic valve implantation (TAVI) system, Evolut R has shown the highest reported survival rate (93.3 percent) for high- and extreme-risk aortic stenosis patients at one-year follow-up, according to data from the Evolut R CE Study that was recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Aortic stenosis is a condition where the aortic valve narrows thereby limiting blood flow from the aorta to the rest of the body.

The first patients in the study — a global, multi-center, single-arm, prospective study of up to 1,000 patients — were enrolled at University Hospital in Bonn, Germany, by the team of Prof. Georg Nickenig.

The study will enroll high- and extreme-risk patients in at least 60 centers worldwide and will document the clinical and device performance outcomes of the Evolut R System used in routine clinical practice. The primary endpoint will evaluate all-cause mortality at 30 days post-implant in patients with severe symptomatic aortic valve stenosis. Secondary endpoints will include VARC-2 safety and efficacy. The study is designed to develop rigorous evidence through complete monitoring at all centers, leveraging independent safety review and core-lab adjudicated hemodynamic performance. Follow-up will be conducted at implant, 30 days, one year, two years and three years post-implant.

“Evolut R has demonstrated some of the most promising clinical results of any TAVI valve in its pre-market trial, and we are excited to enroll our patients into this rigorous study to show that the same results can be delivered in a real world clinical setting,” said Prof. Eberhard Grube, M.D., director of the Structural Heart Program at University Hospital in Bonn, Germany, and co-principal investigator of the FORWARD Study.

Built on the foundation and procedural success of the CoreValve System, the CoreValve Evolut R is available in Europe and other countries that recognize the CE (Conformité Européene) Mark and was approved for commercial use in the United States in 2015. Geographies participating in the study include centers in Europe, Australia, the Middle East, Africa, Latin America and Canada.

Data from the Evolut R CE Study, which evaluated high- and extreme-risk patients with aortic stenosis, reported a low, one-year stroke rate at 3.4 percent, strong hemodynamic performance (single-digit gradients at one year), low rates of moderate or severe paravalvular leak (4.3 percent at one year), and low pacemaker implantation rate (15.2 percent one year).

For more information: www.medtronic.com

Related Content

Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab | November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Overlay Init