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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2032-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure, Left Sided

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ContraBand implants

Percutaneous implantation of the ContraBand devices by right heart catheterization

Group Type EXPERIMENTAL

ContraBand implants

Intervention Type DEVICE

Percutaneous implantation of the ContraBand devices by right heart catheterization

Interventions

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ContraBand implants

Percutaneous implantation of the ContraBand devices by right heart catheterization

Intervention Type DEVICE

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No