ContraBand™: FIH Safety & Feasibility Study (RM-20-01)

Launched by RESTORE MEDICAL LTD · Feb 8, 2022

Keywords

ClinConnect Summary

The ContraBand™ clinical trial is studying a new device designed to help patients with chronic heart failure, particularly those who still experience symptoms despite taking their prescribed medications. The ContraBand™ device works by slightly narrowing certain blood vessels in the lungs, which can help improve the heart’s function and make patients feel better. This is the first time the device is being tested in humans, and the study aims to see if it is safe and effective.

To participate in this trial, individuals must be between 18 and 85 years old and have been diagnosed with systolic heart failure for at least three months. They should also be experiencing symptoms and have a specific heart function level. Participants will be closely monitored throughout the study, and they will need to agree to follow-up appointments and tests. It's important to note that certain health conditions, such as severe heart valve problems or recent heart surgery, may prevent someone from joining the trial. This study is currently recruiting participants and hopes to gather valuable information to help improve treatment options for heart failure patients.

Gender

ALL

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