Studies

Featured trials

APOLLO Trial

• Patient Population
  • 18 years and older
• Primary Inclusion
  • Moderate to severe or severe symptomatic mitral regurgitation
  • Condition cannot may not be optimally treated with approved transcatheter repair or conventional mitral valve surgery
• Primary Exclusion
  • Prior transcatheter mitral valve procedure with device currently implanted
  • Anatomic contraindications
  • Prohibitive mitral annular calcification
  • Left ventricular ejection fraction <30%
  • Need for emergent or urgent surgery
  • Hemodynamic instability

• Site
  • San Antonio, TX

PROACTIVE-HF

• Patient Population
  • Diagnosis and treatment of heart failure for ≥ 3 months and NYHA Class III heart failure at time of screening
• Primary Inclusion
  • Male or female, at least 18 years old
  • Stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for heart failure therapy in the United States, with any intolerance documented.
  • HF related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening /Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at time of Screening/ Enrollment defined as:
    • Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
    • Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL .
  • Thresholds for NT-proBNP (for both LVEF ≤ 50% and LVEF > 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
  • Subjects should be on diuretic therapy
  • Subjects with sufficient eyesight, hearing, and mental capacity to respond to audio/visual cues
  • Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
  • Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up
• Primary Exclusion
  • Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNI), and beta-blockers) due to hypotension or renal dysfunction
  • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  • History of recurrent pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (< 3 month prior to Screening Visit)
  • Have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the screening visit
  • Unrepaired severe valvular disease
  • Congenital heart disease or mechanical/tissue right heart valve(s)
  • Coagulation disorders
  • Hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one- month post implant
  • Known history of life-threatening allergy to contrast dye
  • RHC is contraindicated
  • Active infection at the Cordella PA Sensor Implant Visit
  • Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
  • Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
  • Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or lung or heart transplant) in the next 12 months
  • Pregnant or breastfeeding
  • Unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
  • Severe illness, other than heart disease, which would limit survival to <1 year
  • Clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
  • Enrolled in another clinical study
• Site
  • San Antonio, TX

COMPETENCE

• Patient Population
  • Left Ventricular Ejection Fraction (LVEF) ≤ 25%
  • NYHA Class IV heart failure
• Primary Inclusion
  • Age ≥ 18 years
  • Patient is able to provide written informed consent
  • More detailed inclusion criteria information is noted in the study protocol
• Primary Exclusion
  • Active, uncontrolled infection
  • Severe end organ dysfunction or failure
  • History of any organ transplant
  • Prosthetic mechanical aortic valve that will not be converted to a bioprosthesis
  • Patients with an unacceptable risk for successful LVAD implantation and maintenance
  • Patients refusing blood transfusion
  • Intolerant of anticoagulation therapy
  • Active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or their medical regimen
  • Pregnancy
  • Current dependence on other mechanical circulatory support device at the time of implant, other than IABP and Impella 5.0/5.5
  • Presence of condition other than heart failure that would limit survival to less than 24 months
  • More detailed exclusion criteria information is noted in the study protocol
• Site
  • San Antonio, TX

Enrolling trials

• CorCinch – LV Function
• DAPA ACT HF – Dapagliflozin in-hospital initiation
• Guide HF – CardioMEMS Device
• Proactive HF – Cordella System Hemodynamic Monitoring
• Protected TAVR – Sentinel Cerebral Protection System
• Reduce PAS – PFO Closure
• Relieve HF – Interatrial Shunt
• STEMI DTU – Unloading and Delayed Reperfusion
• Surpass – Outcomes with Impella 5.5
• SWIFT – HeartMate 3 (LVAD) Surgical Techniques other than full sternotomy
• Triluminate – Tricuspid Clip
• UNISUS – Macitentan Dosing Study

Trials in Follow-Up

• Alnylam – Patisiran Drug Study
• Low Risk TAVR - Low Risk Population
• Option – WATCHMAN FLX
• SHORE – Surveillance Heartcare Outcomes Registry
• SPHERE – Uptravi Registry