ContraBand™: Safety & Feasibility Study (RM-20-01)
Recruiting
N/A
Interventional Study
Heart Failure, Left Sided
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
- Treatment
- Participants needed
- 55 (estimated)
- Sponsor
- Restore Medical Ltd · Industry
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About This Trial
ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in a lower distal systolic pulmonary artery pressure (PAP) as well as an attenuation in the rise of the mean pulmonary capillary wedge pressure (PCWP) along with a higher pul…
Trial Locations
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Eligibility Criteria
Main Inclusion Criteria:
* Age is 18 - 85 years old
* Chronic heart failure (\> 3 months)
* Symptomatic left heart failure Stage C (NYHA Class III-IVa) or Class II with documented prior history of Class III-IVa heart failure.
* LVEF 20 - 40%
* Receiving optimally tolerated GDMT for at least 3 (thre…
Contacts