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

Heart Failure, Left Sided Clinical Trial

Official title:

ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230745
• Other study ID #: RM-20-01
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Restore Medical Ltd
• Contact: Stephen Bellomo
• Phone: +972 54 227 4831
• Email: stephen[@]restoremedical.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Left Sided

Intervention

Device:
• ContraBand implants
Percutaneous implantation of the ContraBand devices by right heart catheterization

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi
Israel	Kaplan Medical Center	Re?ovot
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Poland	Clinical Site	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Restore Medical Ltd

Countries where clinical trial is conducted

Belgium,  Georgia,  Israel,  Lithuania,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-related or procedure-related major adverse events (MAEs)	MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; embolization and heart failure- related hospitalization.	30 days
Secondary	Procedural success	Ability to successfully deliver devices to the Pulmonary Arteries	Implantation procedure