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

Restore Medical

Status

Enrolling

Conditions

Heart Failure, Left Sided

Treatments

Device: ContraBand implants

Study type

Interventional

Funder types

Industry

Identifiers

NCT05230745

RM-20-01

Details and patient eligibility

About

ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in a lower distal systolic pulmonary artery pressure (PAP) as well as an attenuation in the rise of the mean pulmonary capillary wedge pressure (PCWP) along with a higher pulmonary arterial compliance (PAC) distal to the constriction during exercise. Lower PCWP reflects the reduced left ventricular end diastolic pressure (LVEDP), contributing to enhanced ventricular filling and improved cardiac output. This hemodynamic change is anticipated to translate into enhanced physical capacity and a potentially more favorable prognosis for heart failure subjects. This study is an early feasibility, multi center, prospective, interventional, open-label, single-arm study.

Enrollment

55 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and 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