Evaluation of the safety and efficacy of the Optimizer™ II and III systems with active fixation leads in subjects with heart failure resulting from systolic dysfunctio

Impulse Dynamics Inc. (USA)0 sites250 target enrollmentJuly 20, 2006

ConditionsHeart failure Circulatory System

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart failure
Sponsor: Impulse Dynamics Inc. (USA)
Enrollment: 250
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 20, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Impulse Dynamics Inc. (USA)

Eligibility Criteria

Inclusion Criteria

•1\. Age \- subjects who are 18 years of age or older
•2\. Gender \- subjects who are either male or female
•3\. Condition:
•3\.1\. Subjects with moderate to severe heart failure as evidenced by a baseline peak oxygen uptake between 10 and 20 ml O2/min/kg
•3\.2\. Subjects with baseline ejection fraction of 35% or less by echocardiography
•3\.3\. Subjects who are on optimal medical therapy for heart failure, consisting of the appropriate medications, doses and duration of treatment based on standard of care for the institution. Guidelines for defining optimal medical therapy and minimum durations of treatment may vary among participating centers. However, the following set of guidelines regarding minimum duration of treatment shall be required for each class of drugs:
•3\.3\.1\. Diuretics \- sufficient dose for at least two weeks so that the subject is clinically euvolemic
•3\.3\.2\. Angiotensin converting enzyme (ACE)\-inhibitor or angiotensin II receptor blocker at a stable dose for at least two weeks
•3\.3\.3\. Digoxin for at least two weeks
•4\. Beta\-blocker:

Exclusion Criteria

•1\. Subjects with a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease
•2\. Subjects with evidence of active ischemia consisting of, for example, angina or electrocardiogram (ECG) changes during exercise testing)
•3\. Subjects who have been hospitalized within one month prior to enrolment for heart failure, which has required the use of intravenous diuretics or inotropic support
•4\. Subjects without an ICD who have a documented history of sustained ventricular tachycardia (VT), or who have an indication for and ICD and are not scheduled for ICD implantation
•5\. Subjects with an ICD who have had appropriate ICD firing during the past one month
•6\. Subjects who have a clinically significant amount of ambient ectopy, defined as more than a total of 8,900 premature ventricular contractions (PVCs) per 24 hours on baseline Holter monitoring
•7\. Subjects with chronic atrial fibrillation or chronic atrial flutter
•8\. Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g. angina, chronic obstructive pulmonary disease (COPD), peripheral vascular disease, orthopedic or rheumatologic conditions)
•9\. Subjects who are unable to participate in a six\-minute walk and/or a cardiopulmonary stress test
•10\. Subjects who are scheduled for a coronary artery bypass grafting (CABG) or a percutaneous transluminal coronary angioplasty (PTCA) procedure, or who have undergone a CABG procedure within three months or a PTCA procedure within one month of enrolment