Use of the Impella BTRâ„¢ in Patients With Heart Failure: An Early Feasibility Study (NCT05291884) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Use of the Impella BTRâ„¢ in Patients With Heart Failure: An Early Feasibility Study
United States10 participantsStarted 2022-04-20
Plain-language summary
This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTRâ„¢ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of the Impella BTRâ„¢ in supporting patients to recovery or their next therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years
✓. Subject has signed the Informed Consent
✓. Subject has pre-existing heart failure, with NYHA Class IV prior to the index admission
✓. Subject is presenting with acute heart failure and meets one of the following criteria:
✓. Sustained episode of systolic blood pressure ≤90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure
✓. Or a cardiac index (CI) \<2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
✓. Or required support with an intra-aortic balloon pump
Exclusion criteria
✕. Structural aortic valve regurgitation or stenosis of any grade greater than mild, with evidence of aortic sclerosis on pre-procedure echocardiography
✕. New diagnosis of heart failure ≤90 days prior to enrollment
✕. Previous aortic valve replacement or reconstruction
✕. Prealbumin \<150 mg/L (15 mg/dL) or Albumin \<30 g/L (3 g/dL)
✕. Thrombus in the left atrium or ventricle
✕. STEMI ≤30 days prior to enrollment
What they're measuring
1
Feasibility: successful hemodynamic support
Timeframe: Device explant or 28 days, whichever is shorter
2
Safety: Major Device-Related Adverse Events
Timeframe: From date of enrollment to 28 days or discharge from hospital
. Severe Cardiogenic Shock during index hospitalization - requiring multiple pressors, currently on mechanical circulatory support (not including IABP) or mechanical ventilation or experiencing PEA or refractory VT/VF
✕. Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition or any global or functional neurological deficit.