Status:
COMPLETED
Clinical Benefits in Optimized Remote HF Patient Management
Lead Sponsor:
Abbott Medical Devices
Conditions:
Congestive Heart Failure Treated
Eligibility:
All Genders
Phase:
NA
Brief Summary
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of re...
Detailed Description
The outcome measure of the study is a combined endpoint of: * Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrilla...
Eligibility Criteria
Inclusion
- Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1
- 1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months
- Left Bundle Branch Block (LBBB)
- Patients must be able to provide written informed consent
- Patients are mentally capable to participate in the Investigation (based on physician's discretion)
Exclusion
- Patients already implanted with CRT or CRT-D device to be replaced
- Patients in long-standing persistent or permanent AT/AF
- Patients in dialysis treatment at the time of enrollment
- Patients in parenteral inotropic therapy at the time of enrollment
- Patients with epicardial Left Ventricular (LV) lead
- Patients with mechanical valvular prosthesis
- Patients with life expectancy \< 12 months
- Patients actively considered for cardiac transplant
- Patients \< 18 years old
- Pregnant women
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01482598
Start Date
October 1 2011
End Date
September 1 2016
Last Update
November 16 2020
Active Locations (18)
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1
Casa di Cura "Montevergine"
Mercogliano, Avellino, Italy
2
Ospedale Pietro Cosma
Camposampiero, Padova, Italy
3
Osp. S.Raffaele Giglio
Cefalù, Palermo, Italy
4
Presidio Ospedaliero Riunito di Ciriè
Cirié, Torino, Italy