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

Not Applicable

Recruiting

• Conditions: Heart Failure, Left Sided
• Interventions: Device: ContraBand implants

• Registration Number: NCT05230745
• Lead Sponsor: Restore Medical Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-07
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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)

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ContraBand implants	ContraBand implants	Percutaneous implantation of the ContraBand devices by right heart catheterization

Primary Outcome Measures

Name	Time	Method
Device-related or procedure-related major adverse events (MAEs)	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Procedural success	Implantation procedure	Ability to successfully deliver devices to the Pulmonary Arteries

Trial Locations

Locations (5)

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia

Kaplan Medical Center; 🇮🇱 Reẖovot, Israel

Clinical Site; 🇵🇱 Lublin, Poland

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Vilnius University Hospital Santaros Klinikos; 🇱🇹 Vilnius, Lithuania