Multisite Pacing With a Quadripolar Lead
Phase 4
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT00964938
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method dP/dt max acute: during implant procedure; 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Montreal Heart Institute
đŸ‡¨đŸ‡¦Montreal, Quebec, Canada