Characterization of Cardiac Hemodynamics During MultiSite Pacing
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT01564186
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this study is to evaluate the effects of MultiPoint Pacing (MPP) on cardiac hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class assessment and echocardiographic measurements are performed at 3 months and 12 months post-implant to characterize long-term effect of MPP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Be scheduled to undergo implant of a St Jude Medical CRT-D system with approved standard indication by ESC/EHRA Guidelines
- Be in sinus rhythm at the time of enrollment
- Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule
Exclusion Criteria
- Exhibit Cheyne-Stokes respiration
- Have persistent or permanent atrial fibrillation
- Have complete heart block
- Be in NYHA IV functional class
- 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 in the following 7 months
- Have had a recent CVA or TIA within 3 months prior to enrollment
- Have had intravenous inotropic support in the last 30 days
- Be less than 18 years of age
- Be pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Within-patient differences in PV loop-based hemodynamic parameters (dP/dtMax, stroke work, stroke volume, ejection fraction) At implant
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maria Cecilia Hospital
🇮🇹Cotignola, Italy