Arrythmia Burden in Cardiac Contractility Modulation (CCM)

TerminatedOBSERVATIONAL
Enrollment

2

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

July 18, 2023

Study Completion Date

July 18, 2023

Conditions
Atrial FibrillationArrythmia
Interventions
DEVICE

Impulse Dynamics Optimizer Device

The Impulse Dynamics Optimizer is indicated for patients with New York Heart Association (NYHA) class III congestive heart failure (CHF) with left ventricular ejection fraction (LVEF) between 25 and 45% who are not candidates for cardiac resynchronization therapy. The Optimizer device requires a minimally invasive implant by a cardiac electrophysiologist with two transvenous pacemaker wires implanted into the right ventricular septum and attached to a generator in an infraclavicular region, much like a pacemaker. The Optimizer device provides CCM through improved calcium handling and has been shown to reverse the negative remodeling of the left ventricle seen in HFrEF and improve left ventricular contractile strength.

Trial Locations (1)

07601

Hackensack Univeristy Medical Center, Hackensack

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Impulse Dynamics

INDUSTRY

lead

Hackensack Meridian Health

OTHER

NCT05704426 - Arrythmia Burden in Cardiac Contractility Modulation (CCM) | Biotech Hunter | Biotech Hunter