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