ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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 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.

• 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.

Locations
Other Locations
Belgium
ZNA Middelheim
RECRUITING
Antwerp
Georgia
Tbilisi Heart and Vascular Clinic
RECRUITING
Tbilisi
Israel
Kaplan Medical Center
RECRUITING
Rehovot
Lithuania
Vilnius University Hospital Santaros Klinikos
RECRUITING
Vilnius
Poland
Clinical Site
NOT_YET_RECRUITING
Lublin
Contact Information
Primary
Stephen Bellomo
stephen@restoremedical.co
+972 54 227 4831
Time Frame
Start Date: 2021-10-07
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 55
Treatments
Experimental: ContraBand implants
Percutaneous implantation of the ContraBand devices by right heart catheterization
Related Therapeutic Areas
Sponsors
Leads: Restore Medical Ltd

This content was sourced from clinicaltrials.gov