Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

Completed · Not applicable

Conditions studied: Heart Failure

In brief

The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

Key facts

Study ID

NCT03089281

Run by

Boston Scientific Corporation

People needed

699

Starts

2017-08-01

Expected to finish

2020-09-15

Last updated by the study team

2022-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
• In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
• Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
• Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
• Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
• Subject is willing and capable of providing informed consent
• Subject is willing and capable of complying with visits and procedures as defined by this protocol

You may not qualify if…

• Subjects with documented permanent complete AV block
• Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
• Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
• Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
• Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
• Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
• Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
• Women of childbearing potential who are or plan to become pregnant during the course of the trial
• Subjects currently requiring dialysis

Where it is running

• Heart Center Research LLC — Huntsville, Alabama, United States
• University of Arizona Sarver Heart Center — Tucson, Arizona, United States
• Cardiology Associates of NE Arkansas — Jonesboro, Arkansas, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Salinas Valley Memorial Healthcare System — Salinas, California, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Baptist Health Research Institute — Jacksonville, Florida, United States
• Watson Clinic Center for Research, Inc — Lakeland, Florida, United States
• Winter Haven Hospital — Winter Haven, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• The University of Chicago — Chicago, Illinois, United States
• St. John's Hospital — Springfield, Illinois, United States
• Heart Group at Deaconness Hospital — Newburgh, Indiana, United States
• University of Iowa Hospitals — Iowa City, Iowa, United States
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Southcoast Health — Fall River, Massachusetts, United States
• Cardiovascular Institute of Michigan — Roseville, Michigan, United States
• Trinity Health Michigan d/b/a Michigan Heart — Ypsilanti, Michigan, United States
• HealthEast St. Joseph's Hospital — Saint Paul, Minnesota, United States
• The International Heart Institute on Montana Foundation — Missoula, Montana, United States
• Cardiovascular Associates of the Delaware Valley — Haddon Heights, New Jersey, United States
• Affinity Hospital, LLC d/b/a Granview Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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