New device for treating heart failure symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Stephen Bellomo
• Email: stephen@restoremedical.co
• Phone: +972 54 227 4831

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.