N/A
Completed N=139
Clinical Benefits in Optimized Remote HF Patient Management
Congestive Heart Failure Treated
Source: ClinicalTrials.gov NCT01482598 ↗
Enrolled (actual)
139
Serious AEs
46.8%
Results posted
Nov 2020
Primary outcomePrimary: Combined Endpoint on Patient Clinical Outcome
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 recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. The remote care allows early intervention in terms of drug therapy adjustment and cardiac resynchronization therapy (CRT-D) device reprogramming.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Endpoint on Patient Clinical Outcome |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01482598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.