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

Primary Purpose

Heart Failure, Left Sided

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ContraBand implants
Sponsored by
Restore Medical Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Left Sided focused on measuring pulmonary artery banding

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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/device therapy for last 1 month
  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:

  1. Serum NT-proBNP <300
  2. Significant level of RV dysfunction as determined by clinical exam, echo, and hemodynamic evaluation
  3. Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™
  4. Restrictive Cardiomyopathy or myocarditis
  5. Patients with congenital heart disease and/or mechanical heart valve(s)
  6. Any severe valve disease (Grade 3-4)
  7. Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
  8. Active bacterial endocarditis or previous history of SBE (Subacute bacterial endocarditis)
  9. Acute kidney insufficiency and/or end stage renal disease requiring chronic dialysis (eGFR < 30)
  10. Leukopenia (WBC < 4000 cells/μL), anemia (Hgb < 9 g/dL), thrombocytopenia (platelets < 150,000 cells/μL) or any known blood clotting disorder

Sites / Locations

  • ZNA MiddelheimRecruiting
  • Tbilisi Heart and Vascular ClinicRecruiting
  • Kaplan Medical CenterRecruiting
  • Vilnius University Hospital Santaros KlinikosRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ContraBand implants

Arm Description

Percutaneous implantation of the ContraBand devices by right heart catheterization

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Procedural success
Ability to successfully deliver devices to the Pulmonary Arteries

Full Information

First Posted
January 5, 2022
Last Updated
February 8, 2022
Sponsor
Restore Medical Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05230745
Brief Title
ContraBand™: FIH Safety & Feasibility Study (RM-20-01)
Official Title
ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Restore Medical Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Left Sided
Keywords
pulmonary artery banding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ContraBand implants
Arm Type
Experimental
Arm Description
Percutaneous implantation of the ContraBand devices by right heart catheterization
Intervention Type
Device
Intervention Name(s)
ContraBand implants
Intervention Description
Percutaneous implantation of the ContraBand devices by right heart catheterization
Primary Outcome Measure Information:
Title
Device-related or procedure-related major adverse events (MAEs)
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedural success
Description
Ability to successfully deliver devices to the Pulmonary Arteries
Time Frame
Implantation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age is 18 - 85 years old Chronic (> 3 months) systolic heart failure Symptomatic left heart failure Stage C (NYHA II-IVa) LVEF 20-40% Patients on optimal tolerated medical/device therapy for last 1 month 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: Serum NT-proBNP <300 Significant level of RV dysfunction as determined by clinical exam, echo, and hemodynamic evaluation Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™ Restrictive Cardiomyopathy or myocarditis Patients with congenital heart disease and/or mechanical heart valve(s) Any severe valve disease (Grade 3-4) 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Bellomo
Phone
+972 54 227 4831
Email
stephen@restoremedical.co
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerpen
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Kaplan Medical Center
City
Reẖovot
Country
Israel
Individual Site Status
Recruiting
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
Country
Lithuania
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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