New device for treating heart failure symptoms
ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure
This study is testing a new device for people with heart failure to see if it can help improve their symptoms when other treatments aren't working.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Restore Medical Ltd Industry-sponsored |
| Locations | 12 sites (Aalst and 11 other locations) |
| Trial ID | NCT05230745 on ClinicalTrials.gov |
What this trial studies
The ContraBand™ device is designed for patients with heart failure who continue to experience symptoms despite optimal medical therapy. This innovative transcatheter device is implanted in the pulmonary arteries to create a constriction, which may help reposition the interventricular septum and improve heart function. This first-in-human study aims to assess the safety and feasibility of the ContraBand™ in a multi-center, prospective, open-label format. Participants will be closely monitored to evaluate the device's impact on their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with chronic systolic heart failure who are symptomatic despite optimal medical therapy.
Not a fit: Patients with significant right ventricular dysfunction or severe pulmonary hypertension may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this device could significantly improve the quality of life for heart failure patients who are not responding to current treatments.
How similar studies have performed: While this approach is novel, similar interventions in heart failure have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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 (three) months as referred in the 2021 ESC Guidelines for the optimal recommended pharmacological treatment indicated in patients with (NYHA class II-IV) heart failure with reduced ejection fraction (LVEF\< 40%). * If indicated according to the 2021 ESC Guidelines: Subject has an implantable cardioverter-defibrillator (ICD) for at least 1 month prior to screening. or subject is on cardiac resynchronization therapy (CRT)/pacemaker for at least 3 months prior to screening. * Able to complete six-minute walk test (6MWT) with distance between 100 meters and 400 meters. Main Exclusion Criteria: * Serum NT-proBNP \<300 pg/mL * Significant RV dysfunction with TAPSE \< 15 mm * Moderate to severe pulmonary hypertension (Pulmonary vascular resistance PVR ≥ 4.0 WU and PAPi \< 1.0 by RHC) * Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™ * Restrictive Cardiomyopathy or myocarditis * Any severe valve disease (Grade 3-4) and/or tricuspid regurgitation ≥ 2+ (in a scale of 5) * Hemodynamic instability: Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support * Active bacterial endocarditis or previous history of SBE (Subacute bacterial endocarditis) * Any planned cardiac surgery or interventions within the next six (6) months * Need for coronary artery revascularization * Myocardial infarction or any percutaneous cardiovascular intervention within 1 month * Cardiovascular surgery, or carotid surgery within 3 months * Acute kidney insufficiency and/or end stage renal disease requiring chronic dialysis (eGFR \< 30) * Leukopenia (WBC \< 4000 cells/μL), anemia (Hgb \< 9 g/dL), thrombocytopenia (platelets \< 150,000 cells/μL) or any known blood clotting disorder * History of systemic or pulmonary thromboembolism within 12 months prior to Baseline visit; incidental small peripheral pulmonary emboli deemed clinically insignificant by the investigator are not considered exclusionary * Previous history of cardiogenic shock (unrelated to myocardial infraction) * Stroke, transient ischemic attack (TIA) or deep vein thrombosis (DVT) within 6 months of screening
Where this trial is running
Aalst and 11 other locations
- Clinical Site — Aalst, Belgium (Recruiting)
- Clinical Site — Antwerp, Belgium (Recruiting)
- Clinical Site — Genk, Belgium (Recruiting)
- Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia (Recruiting)
- Clinical Site — Lübeck, Germany (Recruiting)
- Clinical Site — Nahariya, Israel (Recruiting)
- Clinical Site — Petah Tikva, Israel (Recruiting)
- Kaplan Medical Center — Rehovot, Israel (Recruiting)
- Clinical Site — Klaipėda, Lithuania (Recruiting)
- Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania (Recruiting)
- Clinical Site — Krakow, Poland (Recruiting)
- Clinical Site — Lublin, Poland (Recruiting)
Study contacts
- Study coordinator: Stephen Bellomo
- Email: stephen@restoremedical.co
- Phone: +972 54 227 4831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.