Heart Failure
Conditions
Keywords
Hemodynamic response, Cardiac resynchronization therapy
Brief summary
The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.
Interventions
DEVICEQuadripolar LV lead (pacing configurations)
Quadripolar LV lead will be used to deliver a combination of pacing configurations
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a scheduled CRT implantation at the participating clinical study site * Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms * Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation * Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations
Exclusion criteria
* Have persistent or permanent atrial fibrillation * Have an intrinsic heart rate of \<50 beats per minute * Have a recent myocardial infarction within 40 days prior to enrollment * Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures * Have had a recent CVA or TIA within 3 months prior to enrollment * Have had intravenous inotropic support in the last 30 days * Have ischemic etiology and are unable to tolerate stress echocardiography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dP/dt max | acute: during implant procedure; 1 day |
Countries
Canada
Outcome results
None listed