Heart Failure Management for Patient With CIED Remotely Monitored
Recruiting
N/A
Interventional Study
Heart Failure
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure With Reduced Ejection Fraction (HFrEF)
Heart Failure With Decompensation
CRT and/or ICD
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,132 (estimated)
- Sponsor
- Implicity · Industry
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About This Trial
This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart failure. The primary objective is to determine whether SmartSignalHF reduces all-cause mortality and HF hospitalizations at 12 months.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient aged 18-85
* Patient diagnosed with a New York Heart Association (NYHA) class II or III
* Patients with left ventricular ejection fraction ≼ 40 %
* Patient implanted with an ICD or CRT-D (BiV and/or LBBA pacing) since at least 30 days and compatible with SignalHF (Biot…
Contacts
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