Minneapolis Heart Institute Foundation

Electrophysiology Research / Joseph F. Novogratz Family Heart Rhythm Center

Q2 2025

Center Highlights

LEADR LBBAP: First site in the world to complete enrollment in the LEADR LBBAP trial evaluating safety and efficacy of the next generation ICD lead placed in the LBBAP location in patients with an ICD or LOT-CRT.

Affera Catheter: Dr. Jay Sengupta led the team at AHMHI who successfully performed the first procedure at Abbott Northwestern Hospital using the Affera Mapping and Ablation System with Sphere-9 Catheter from Medtronic. The system enables physicians to customize treatment based on a patient’s needs during an ablation procedure, providing a life-changing solution for people with AFib. Read more

Study Spotlight: Aim HIGHer

Description

The study will assess the efficacy and safety of Cardiac Contractility Modulation therapy over an estimated duration of 5-6 years from first enrollment to study closure. The key inclusion criteria for this study are patients with symptomatic heart failure with a left ventricular ejection fraction ≥40 and ≤70%.

Contact

Efrah Hussein

Efrah.hussein@allina.com

Principal Investigator

Dr. Mike Samara

Enrolling Clinical Studies

Study

Study Description

PI and Enrolling Sites

SURVEILLANCE

Medtronic

Provide continuing evaluation of multiple market-released pacing and ICD leads.

Dr. JoEllyn Moore

ANW and United

Optimizer PAS

Impulse Dynamics, Inc.

Evaluate clinical outcomes of Cardiac Contractility Modulation therapy in patients with HFrEF, and interactions with other implantable devices.

Dr. Jay Sengupta

ANW

AIM HIGHer

Impulse Dynamics, Inc.

Evaluate the efficacy and safety of Cardiac Contractility Modulation therapy in patients with symptomatic HF with LVEF 40-60%.

Dr. Mike Samara

ANW

Pipeline Studies

BackBeat

Orchestra BioMed, Inc.

Evaluate the safety and effectiveness of a novel atrioventricular interval modulation algorithm in reducing blood pressure for patients with a dual-chamber pacemaker and uncontrolled hypertension despite antihypertensive medications.

Dr. Jay Sengupta

ANW

Sphere-360 IDE

Medtronic

Demonstrate the safety and effectiveness of the Sphere-360TM Catheter and Affera TM Mapping and Ablation System for the treatment of recurrent, symptomatic PAF.

Dr. Jay Sengupta

ANW

OMNY-AF

Biosense Webster

Assess the safety and effectiveness of the OMNYPULSE PFA Platform for PVI in the treatment of subjects with symptomatic PAF.

Dr. Dan Melby

ANW

Abbreviations: ANW= Abbott Northwestern Hospital; PVI= pulmonary vein isolation; HF= heart failure; ICD=implantable cardiac defibrillator; LBBAP= left bundle branch area pacing; CRT= cardiac resynchronization therapy; LOT-CRT= Left bundle branch-optimized cardiac resynchronization therapy; PAF= persistent atrial fibrillation; AHMHI- Abbott Hospital Minneapolis Heart Institute; LVEF= left ventricular ejection fraction; HFrEF = heart failure with reduced ejection fraction

For more information, please contact Julianne Feola at Julianne.Feola@allina.com