Minneapolis Heart Institute Foundation

Structural Research / Valve Science Center Update

October 2025 Bi-Annual Update

Research Impacting Clinical Practice Around the World

Dr. João Cavalcante and his team’s contributions in advanced cardiac imaging research played an important role in shaping the ESC/EACTs 2025 Valvular Guidelines to:

Expand the use of CTA for pre-TAVR evaluation of coronary artery disease
Identify volumetric thresholds for intervention in patients with asymptomatic, severe aortic regurgitation

Clinical Trial Excellence Contributing to FDA Approval of the Tendyne™ System

MHIF was one of the top enrolling sites in the SUMMIT trial, which contributed to FDA approval of the Tendyne™ TMVR system for the treatment of mitral valve disease due to severe mitral annular calcification.

Award Winning Procedural Planning App: Redo-TAV

Congratulations to Drs. Vinnie Bapat, Miho Fukui, and Atsushi Okada, along with Mady Olson, on being honored with the Global Cardiovascular Collaboration of the Year Award for their outstanding work on the Redo-TAV App.

Study Spotlight: SMARTER-CMR

Description

Study evaluating the impact of LV myocardial fibrosis extent assessed by cardiac magnetic resonance (CMR) on LV reverse remodeling and clinical outcomes post-transcatheter edge-to-edge repair (TEER).

Enrolling patients with heart failure and reduced ejection fraction, medically and device-optimized according to guidelines with signification functional mitral regurgitation undergoing TEER with MitraClip.

Contact

Sarah Schwager

Sarah.Schwager@allina.com

612-863-6257

Principal Investigator

Dr. João Cavalcante

Enrolling Clinical Studies

Aortic

Study

Device

PI & Enrolling Site

ALIGN AR

JenaValve Technology

JenaValve Trilogy™ TAVR system pivotal trial for the treatment of patients with symptomatic, severe aortic regurgitation.

Dr. Konstantinos Voudris

ANW

ARTIST

JenaValve Technology

JenaValve Trilogy™ TAVR system vs. SAVR for patients with clinically significant native aortic regurgitation

Dr. Mario Goessl

ANW

JenaVAD

JenaValve Technology

TAVR for patients with a continuous flow left ventricular assist device

Dr. Konstantinos Voudris

ANW

PROGRESS CAP

Edwards Lifesciences

TAVR with current SAPIEN™ systems vs. clinical surveillance for patients with moderate aortic regurgitation

Dr. Bilal Murad

United

RESTORE

Medtronic

Registry for patients undergoing redo TAVR with Evolut™ and SAPIEN™ THV systems.

Dr. Vinayak Bapat & Dr. Konstantinos Voudris

ANW

Mitral

AltaValve Pivotal/ATLAS

4C Medical Technologies

AltaValve™ System for treatment of patients with moderate-to-severe MR despite optimal GDMT, and unsuitable for surgery and TEER.

Dr. Vinayak Bapat

ANW

APOLLO

Medtronic

Mitral valve replacement with the Intrepid™ TMVR system for patients with moderate-to-severe or severe symptomatic mitral regurgitation, with or without MAC. TMV Replacement

Dr. Mario Goessl

ANW

Tricuspid

VISTA-US

Vdyne, Inc

Transcatheter tricuspid valve replacement for patients with symptomatic severe primary or secondary tricuspid regurgitation.

Dr. Konstantinos Voudris

ANW

TRICAV ll

P+F Products

TricValve® Bicaval Valve System to treat tricuspid regurgitation and caval reflux in patients with severe tricuspid regurgitation, NYHA Calss III-IVa HF admission, and on stable OMT.

Dr. Konstantinos Voudris

ANW

Pipeline Studies

BE TAVI

Abbott

Balloon expandable TAVR System for patients with aortic stenosis

Dr. Vinayak Bapat

DurAVR® THV

Anteris

Balloon expandable TAVR System for patients with aortic stenosis

Dr. Vinayak Bapat

Journey

Edwards

J-Valve TAVR System for patients with symptomatic, severe aortic stenosis

Dr. Konstantinos Voudris

ANW=Abbott Northwestern; EACTS=European Association for Cardio-thoracic Surgery; ESC=European Society of Cardiology; FDA=Food & Drug Association; GDMT=Guideline-Directed Medical Therapy; LV=Left Ventricle; MAC=Mitral Annular Calcification; MR = Mitral Regurgitation; NYHA=New York Heart Association; OMT=Optimized Medical Therapy; PI=Principal Investigator; TAV=Transcatheter Aortic Valve; TAVI=Transcatheter Aortic Valve Implantation; TAVR=Transcatheter Aortic Valve Replacement; TEER=transcatheter edge-to-edge repair; TMVR=Transcatheter Mitral Valve Replacement; TTV=Transcatheter Tricuspid Valve

For more information, please contact Nikki Degeneffe at Nikki.Degeneffe@allina.com; Ph: 612-863-6286

Interested in clinical trials from our other areas of cardiovascular research? Visit mplsheart.org/archive for any recent emails you may have missed.