Heart Failure
Conditions
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.
Interventions
DEVICECRT device implant with MultiPoint Pacing
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| end-systolic volume | 6 months |
Countries
Italy
Outcome results
None listed