Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

Stopped early · Not applicable

Conditions studied: Heart Failure, Congestive Heart Failure, Chronic Heart Disease, CHF

In brief

This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.

Key facts

Study ID

NCT03102437

Run by

Impulse Dynamics

People needed

106

Starts

2017-07-01

Expected to finish

2019-12-16

Last updated by the study team

2021-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are 18 years of age or older
• Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography.
• Subjects who, in the opinion of the Investigator (based on the current guidelines for clinical practice), have been treated for heart failure for at least 90 days and are currently receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure.
• Subjects who are in New York Heart Association functional Class III and IV at the time of enrollment.
• Subjects who are willing and able to return for all follow-up visits.

You may not qualify if…

• Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
• Subjects receiving any form of inotropic support within 30 days before enrollment, including subjects on continuous IV inotrope therapy.
• Subjects hospitalized for decompensated heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing.
• Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
• Subjects having a PR interval greater than 375ms.
• Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
• Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
• Subjects who have had a myocardial infarction within 90 days of enrollment.
• Subjects who have mechanical tricuspid valve.
• Subjects who have a Left Ventricular Assist Device or prior heart transplant.
• Subjects on dialysis.
• Subjects who are participating in another experimental protocol.
• Subjects who are unable to provide informed consent.

Where it is running

• Chan Heart Rhythm Institute — Mesa, Arizona, United States
• Southwest Cardiology Associates — Mesa, Arizona, United States
• Cardiovascular Consultants — Phoenix, Arizona, United States
• Arizona Arrhythmia Consultants — Scottsdale, Arizona, United States
• Pima Heart — Tucson, Arizona, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• St. Mary Research Institute — Langhorne, Pennsylvania, United States
• Jefferson Heart Institute — Philadelphia, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Guthrie Medical Group at Robert Packer Hospital — Sayre, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• CHRISTUS Trinity Mother Frances Health System — Tyler, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.