Status:
COMPLETED
Selection of Potential Predictors of Worsening Heart Failure
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Multicentre study with the objective to correlate heart failure hospitalizations and deaths with Home Monitoring data in ICD/CRT-D recipients, in order to identify the combination of Home Monitoring d...
Detailed Description
Home Monitoring remotely provides continuous trends of potential HF-related variables with a sampling interval of 24 hours. Although the predictive value of individual variables may be limited, a prop...
Eligibility Criteria
Inclusion
- Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- NYHA Class II or III Heart Failure
- Men and women 18 years of age or older
- Understand the nature of the procedure
- Give written informed consent
Exclusion
- No indication or contraindication for ICD or CRT-D therapy
- Permanent AF
- NYHA Class IV Heart Failure
- Subjects with irreversible brain damage from preexisting cerebral disease;
- Subjects with acutely decompensated heart failure
- Expected heart transplantation within next six months or planned cardiac surgery within next 3 months
- Have a life expectancy of less than six months
- Presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer)
- Unstable geographical residence (unable to anticipate to be resident in the area of the referring participating centre during the study period) and/or GSM-free residence
- Subjects who were not been implanted with ICD or CRT-D devices compatible with HM transmissions
- Age \<18 years
- Pregnancy
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
922 Patients enrolled
Trial Details
Trial ID
NCT01836510
Start Date
May 1 2012
End Date
February 28 2017
Last Update
January 18 2020
Active Locations (34)
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1
Cliniche Humanitas Gavazzeni
Bergamo, Italy
2
Spedali Civili
Brescia, Italy
3
Di Summa Hospital
Brindisi, Italy
4
Fondazione Giovanni Paolo II
Campobasso, Italy