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Tests treatment safety and results for Heart Failure, Left Sided
Official title ContraBand™: Safety & Feasibility Study (RM-20-01)
ClinicalTrials.gov ID: NCT05230745
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Main
- 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%
You likely can't join if
- 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)
See the full eligibility criteria
- Main
- 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...
- 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...
- Able to complete six-minute walk test (6MWT) with distance between 100 meters and 400 meters. Main
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Antwerp, Belgium
- Genk, Belgium
- Tbilisi, Georgia
- Lübeck, Germany
- Nahariya, Israel
- Petah Tikva, Israel
- Rehovot, Israel
- Klaipėda, Lithuania
- Vilnius, Lithuania
- Krakow, Poland
- Lublin, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Antwerp, Belgium; Genk, Belgium; Tbilisi, Georgia; Lübeck, Germany; Nahariya, Israel and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.