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

Sponsor
Restore Medical Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05230745
Collaborator
(none)
15
Enrollment
4
Locations
1
Arm
38.8
Anticipated Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ContraBand implants
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure
Actual Study Start Date :
Oct 7, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ContraBand implants

Percutaneous implantation of the ContraBand devices by right heart catheterization

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Procedural success [Implantation procedure]

    Ability to successfully deliver devices to the Pulmonary Arteries

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ZNA Middelheim Antwerpen Belgium
2 Tbilisi Heart and Vascular Clinic Tbilisi Georgia
3 Kaplan Medical Center Reẖovot Israel
4 Vilnius University Hospital Santaros Klinikos Vilnius Lithuania

Sponsors and Collaborators

  • Restore Medical Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Restore Medical Ltd
ClinicalTrials.gov Identifier:
NCT05230745
Other Study ID Numbers:
  • RM-20-01
First Posted:
Feb 9, 2022
Last Update Posted:
Feb 9, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Restore Medical Ltd
pulmonary artery banding
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Feb 9, 2022