NORM-HF Pivotal Study
Recruiting
N/A
Interventional Study
Heart Failure
NYHA Class III Heart Failure
NYHA Class II Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 800 (estimated)
- Sponsor
- Foundry Innovation & Research 1, Limited (FIRE1) · Industry
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About This Trial
This is an international, multi-center, prospective, randomized, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF patients is superior for reducing the combined endpoint of worsening HF events and cardiovascular mortality compared to standard of care treatment. Patients will be randomized in…
Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA:
1. Adults 18 years of age or older.
2. Provide informed consent for participation in the clinical study and be willing and able to comply with the required assessments, treatment instructions, and clinical follow-up visits according to the specified schedule.
3. Patients meeting…
Contacts