Actively Recruiting
ContraBand™: Safety & Feasibility Study (RM-20-01)
Led by Restore Medical Ltd · Updated on 2026-02-05
55
Participants Needed
12
Research Sites
587 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 pulmonary arterial compliance (PAC) distal to the constriction during exercise. Lower PCWP reflects the reduced left ventricular end diastolic pressure (LVEDP), contributing to enhanced ventricular filling and improved cardiac output. This hemodynamic change is anticipated to translate into enhanced physical capacity and a potentially more favorable prognosis for heart failure subjects. This study is an early feasibility, multi center, prospective, interventional, open-label, single-arm study.
CONDITIONS
Official Title
ContraBand™: Safety & Feasibility Study (RM-20-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is 18 - 85 years old
- Chronic heart failure lasting more than 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
- Left ventricular ejection fraction (LVEF) between 20% and 40%
- Receiving optimally tolerated guideline-directed medical therapy (GDMT) for at least 3 months
- If indicated, has an implantable cardioverter-defibrillator (ICD) for at least 1 month or cardiac resynchronization therapy (CRT)/pacemaker for at least 3 months
- Able to complete a six-minute walk test (6MWT) with distance between 100 meters and 400 meters
You will not qualify if you...
- Serum NT-proBNP less than 300 pg/mL
- Significant right ventricular dysfunction with TAPSE less than 15 mm
- Moderate to severe pulmonary hypertension (pulmonary vascular resistance 4.0 WU or higher and PAPi less than 1.0 by right heart catheterization)
- Anatomical issues preventing proper access or implantation of the ContraBand device
- Restrictive cardiomyopathy or myocarditis
- Severe valve disease (Grade 3-4) or tricuspid regurgitation 2+ or higher
- Hemodynamic instability such as low blood pressure (systolic less than 90 mmHg), need for inotropic or mechanical support
- Active bacterial endocarditis or previous history of subacute bacterial endocarditis
- Planned cardiac surgery or interventions within the next 6 months
- Need for coronary artery revascularization
- Myocardial infarction or cardiovascular intervention within 1 month
- Cardiovascular or carotid surgery within 3 months
- Acute kidney failure or end-stage renal disease requiring dialysis (eGFR less than 30)
- Low blood counts including leukopenia, anemia, thrombocytopenia, or known clotting disorders
- History of systemic or pulmonary thromboembolism within 12 months prior to baseline
- Previous history of cardiogenic shock unrelated to myocardial infarction
- Stroke, transient ischemic attack, or deep vein thrombosis within 6 months of screening
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Clinical Site
Aalst, Belgium
Actively Recruiting
2
Clinical Site
Antwerp, Belgium
Actively Recruiting
3
Clinical Site
Genk, Belgium
Actively Recruiting
4
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Actively Recruiting
5
Clinical Site
Lübeck, Germany
Actively Recruiting
6
Clinical Site
Nahariya, Israel
Actively Recruiting
7
Clinical Site
Petah Tikva, Israel
Actively Recruiting
8
Kaplan Medical Center
Rehovot, Israel
Actively Recruiting
9
Clinical Site
Klaipėda, Lithuania
Actively Recruiting
10
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
11
Clinical Site
Krakow, Poland
Actively Recruiting
12
Clinical Site
Lublin, Poland
Actively Recruiting
Research Team
S
Stephen Bellomo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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