MPP Programming Study
Not Applicable
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT01856725
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Be scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system with approved standard indication by ESC/EHRA Guidelines
- 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
- Have high ventricular rate (>90 bpm) during persistent or permanent atrial fibrillation despite available treatment
- Be in NYHA IV functional class
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac bypass 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 or planning to become pregnant during the duration of the investigation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method end-systolic volume 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maria Cecilia Hospital, GVM Care & Research
🇮🇹Cotignola, RA, Italy
Maria Cecilia Hospital, GVM Care & Research🇮🇹Cotignola, RA, Italy