Clinical trial NCT05230745: ContraBand™: FIH Safety & Feasibility Study (RM-20-01)
Official title: ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure, Left Sided
Keywords: pulmonary artery banding
Lead sponsor: Restore Medical Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The ContraBand™ device is intended for treatment of heart failure patients who remain symptomatic despite the use of optimally tolerated guideline directed medical therapy. ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries, causing a local reduction in the internal diameters of these arteries, and resulting in an elevation in systolic right ventricular pressure. This may result in repositioning the interventricular septum to a more normal anatomical position, and supporting it with a "counter-pressure" during systole of the left ventricle. This study is a first-in-human, early feasibility, multi center, prospective, interventional, open-label, single-arm study.


Eligibility criteria: Inclusion Criteria:

1. Age is 18 - 85 years old
2. Chronic (\> 3 months) systolic heart failure
3. Symptomatic left heart failure Stage C (NYHA II\*-IVa)
4. LVEF 20 - 40%
5. Patients on optimal tolerated medical therapy for at least one month. If subject is on device therapy, if ICD for at least 1 month, if CRT/pacemaker, for at least 3 months.
6. Provide a personally signed and dated inform consent form, and able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule.

Exclusion Criteria (selected):

1. Serum NT-proBNP \<300
2. Significant RV dysfunction with TAPSE \<17
3. Pulmonary Hypertension (sPAP \> 45 mmHg by Echo or mPAP \> 20 mmHg by RHC)
4. Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™
5. Restrictive Cardiomyopathy or myocarditis
6. Patients with congenital heart disease and/or mechanical heart valve(s)
7. Any severe valve disease (Grade 3-4) and/or tricuspid regurgitation ≥ 2+ (in a scale of 5)
8. Hemodynamic instability: Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
9. Active bacterial endocarditis or previous history of SBE (Subacute bacterial endocarditis)
10. Any planned cardiac surgery or interventions within the next six (6) months
11. Need for coronary artery revascularization
12. Myocardial infarction or any percutaneous cardiovascular intervention within 1 month
13. Cardiovascular surgery, or carotid surgery within 3 months
14. Acute kidney insufficiency and/or end stage renal disease requiring chronic dialysis (eGFR \< 30)

18. Leukopenia (WBC \< 4000 cells/μL), anemia (Hgb \< 9 g/dL), thrombocytopenia (platelets \< 150,000 cells/μL) or any known blood clotting disorder

Primary outcomes:
measure: Device-related or procedure-related major adverse events (MAEs)
timeFrame: 30 days
Secondary outcomes:
measure: Procedural success
timeFrame: Implantation procedure
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Lublin
country: Poland
facility: Clinical Site
Study officials:
References: