Status:
RECRUITING
ContraBand™: FIH Safety & Feasibility Study (RM-20-01)
Lead Sponsor:
Restore Medical Ltd
Conditions:
Heart Failure, Left Sided
Eligibility:
All Genders
18-85 years
Phase:
NA
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 transcathe...
Eligibility Criteria
Inclusion
- 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 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.
- Exclusion Criteria (selected):
- Serum NT-proBNP \<300
- Significant RV dysfunction with TAPSE \<17
- Pulmonary Hypertension (sPAP \> 45 mmHg by Echo or mPAP \> 20 mmHg by RHC)
- 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) 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)
- 18\. Leukopenia (WBC \< 4000 cells/μL), anemia (Hgb \< 9 g/dL), thrombocytopenia (platelets \< 150,000 cells/μL) or any known blood clotting disorder
Exclusion
Key Trial Info
Start Date :
October 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05230745
Start Date
October 7 2021
End Date
December 31 2026
Last Update
November 18 2023
Active Locations (5)
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1
ZNA Middelheim
Antwerp, Belgium
2
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
3
Kaplan Medical Center
Rehovot, Israel
4
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania