Interventional – Coronary

BioFlow

  • Patient Population
    • Subjects with coronary artery disease (CAD), including those with diabetes, symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries
  • Primary Inclusion
    • Subject received at least one Orsiro stent during an index procedure occurring within 24 hours prior to informed consent
    • Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine.
  • Primary Exclusion
    • Subject had clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) within 72 hours
    • Revascularization of any target vessel within 9 months prior to the index procedure or previous percutaneous coronary intervention (PCI) of any non-target vessel within 30 days prior to the index procedure or any PCI planned within the next 1 year.
    • Subject has documented left ventricular ejection fraction (LVEF) < 30%
  • Site
    • Austin & Round Rock (Roger Gammon, MD)

Ilumien IV

  • Patient Population
    • High clinical-risk or high angiographic-risk lesion characteristics undergoing stent implantation for coronary artery disease.
    • Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia, unstable angina, or acute myocardial infarction) suitable for elective PCI.
  • Primary Inclusion

    • Patients undergoing planned XIENCE stent implantation during a clinically indicated PCI procedure meeting one or more of the following criteria:

      • High clinical-risk – Medication-treated diabetes AND/OR
      • High angiographic-risk lesion(s)
  • Primary Exclusion
    • STEMI ≤24 hours from the onset of ischemic symptoms
    • Hypotension, shock or need for mechanical support or intravenous vasopressors
    • LVEF <30%
    • Unstable ventricular arrhythmias
  • Site
    • Austin (Frank Zidar, MD)

FUSION

  • Patient Population
    • Patients who are clinically indicated for heart cath
  • Primary Inclusion
    • Scheduled for clinically indicated coronary catheterization with the intent to perform physiologic assessment to guide physician clinical course (in lesions with visual % diameter stenosis ≥40%), if clinically indicated
    • Subject is undergoing invasive FFR with Adenosine
  • Primary Exclusion
    • Prior history of myocardial infarction (MI) in the target vessel
    • Presence of acute ST Elevation Myocardial Infarction (STEMI)
    • Prior history of CABG, heart transplant or severe valvular disease
    • Prior history of PCI with stent in target vessel, or target vessel involves in-stent restenosis
  • Site
    • Austin (Frank Zidar, MD)

Congestive Heart Failure

GUIDE-HF

  • Patient Population
    • Symptomatic NYHA III and either prior HF Hospitalization in past 12 months and/or elevated NT-proBNP within 30 days
  • Primary Inclusion
    • Diagnosis and treatment for HF for > 90 days prior to the date of consent and on stable, optimally titrated medical therapy for at least 30 days
    • HF Hospitalization within 12 months prior to consent and/or elevated NT-proBNP (or BNP) within 30 days
  • Primary Exclusion
    • Intolerance to all neuro-hormonal antagonists (angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), and beta-blockers)
    • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
    • Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
  • Site
    • Austin, San Marcos and Round Rock (Kunjan Bhatt, MD)

Relieve-HF

  • Patient Population
    • NYHA II-IV with hospitalization for HF or elevated BNP with guideline directed HF medical therapy
  • Primary Inclusion
    • Ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV ejection fraction and documented heart failure for at least 6 months
    • Receiving guideline directed medical therapy (GDMT) for heart failure which refers to those HF drugs carrying a Class I indication including the following for patients with reduced LVEF (≤40%):
  • Primary Exclusion
    • Resting systolic blood pressure <90 or >160 mmHg after repeated measurements.
    • Severe pulmonary hypertension defined as PA systolic pressure >70 mmHg by echo/Doppler
    • Untreated moderate to severe aortic or mitral stenosis
    • Untreated coronary stenosis which requires surgical or percutaneous intervention
  • Site
    • Austin (Roger Gammon, MD)

DAPA ACT-HF

  • Patient Population
    • Patients with heart failure with reduced ejection fraction (LVEF ≤40%) who have been stabilized during hospitalization for acute heart failure
  • Primary Inclusion
    • Currently hospitalized for AHF defined as meeting all the following criteria: Presentation with worsening symptoms of heart failure, Objective signs or diagnostic testing consistent with volume overload and Intensification of heart failure therapy during admission with at least one of the following: Augmentation of oral diuretic therapy or addition of a second diuretic agent, or new initiation of diuretic therapy
  • Primary Exclusion
    • Symptomatic hypotension in the past 24 hours
    • Use of two or more inotropic agents during the index hospitalization
    • Use of an SGLT2 inhibitor within the last 30 days
    • Prior intolerance of SGLT2 inhibitors
    • Type 1 diabetes mellitus or history of diabetic ketoacidosis
  • Site
    • Austin (Mark Picone, MD) and Round Rock (Sanjay Pandya, MD)

Proactive-HF

  • Patient Population
    • ≥ 18 years of age with a diagnosis of NYHA Class III Heart Failure.
  • Primary Inclusion
    • Diagnosis and treatment of HF for ≥ 3 months and NYHA Class III on stable, optimally titrated medical therapy for at least 30 days
    • HF Hospitalization within 12 months prior to consent and/or elevated NT-proBNP (or BNP) within 30 days
  • Primary Exclusion
    • Intolerance to all neuro-hormonal antagonists (angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), and beta-blockers)
    • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
    • Subjects with history of recurrent (> 2) pulmonary embolism or deep vein thrombosis
    • Unrepaired severe valvular disease
  • Site
    • San Marcos (Faisal Syed, MD)

Valve

Triluminate

  • Patient Population
    • Patients with symptomatic severe Tricuspid Regurgitation despite optimized medical therapy who are at intermediate or greater risk for surgery
  • Primary Inclusion
    • Subject is symptomatic with Severe TR despite being optimally treated
    • NYHA Functional Class II, III or ambulatory class IV
  • Primary Exclusion
    • Systolic pulmonary artery pressure > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
    • Severe uncontrolled hypertension SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg)
    • Any prior tricuspid valve procedure that would interfere with placement of the TriClip™ device
    • Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days
  • Site
    • Austin (Frank Zidar, MD)

CorCinch HFrEF

  • Patient Population
    • Patients with symptomatic heart failure (NYHA III or ambulatory IV, EF≤40%)
  • Primary Inclusion
    • Ejection Fraction: ≥20 and ≤40%
    • NYHA III or ambulatory IV
    • Optimal guideline directed medical therapy
  • Primary Exclusion
    • Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
    • Prior surgical, transcatheter, or percutaneous mitral valve intervention
    • Untreated clinically significant coronary artery disease (CAD) requiring revascularization
    • Any planned cardiac surgery or interventions within the next 6 months
  • Site
    • Austin (Juhana Karha, MD)

CorCinch PMVI

  • Patient Population
    • Patients with recurrent functional mitral regurgitation after a prior mitral valve intervention procedure with symptomatic heart failure
  • Primary Inclusion
    • Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment
    • Ejection Fraction: ≥20 and ≤40% 
    • NYHA III or ambulatory IV
  • Primary Exclusion
    • Patients with significant organic mitral valve pathology
    • Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
    • Prior surgical, transcatheter, or percutaneous mitral valve intervention
    • Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  • Site
    • Austin (Juhana Karha, MD)

WATCH-TAVR

  • Patient Population
    • Patients with non-valvular A-Fib undergoing TAVR
  • Primary Inclusion
    • Patient meets criteria for and is eligible to undergo TAVR procedure
    • Documented paroxysmal, persistent or permanent A-Fib
  • Primary Exclusion
    • Patient had a stroke or TIA within the last 6 months
    • Contraindication for short term anticoagulation
    • Moderate or severe MS with mean gradient across MV >10mmHg of MVA <1.2cm2
    • Patient has symptomatic carotid disease
  • Site
    • Austin (Juhana Karha, MD)

Protected TAVR

  • Patient Population
    • Patients undergoing TAVR procedure
  • Primary Inclusion
    • Subject has documented aortic valve stenosis and is treated with an approved TAVR
    • Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System
  • Primary Exclusion
    • Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery.
    • Subject’s brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
    • Subject has compromised blood flow to the right upper extremity.
    • Subject has uncorrected bleeding disorders.
  • Site
    • Austin (Juhana Karha, MD)

For Women Only

Warrior

  • Patient Population
    • Women with no severe coronary obstruction but with cardiac symptoms
  • Primary Inclusion
    • Signs and symptoms of suspected ischemia prompting referral for further evaluation by cardiac catheterization, or coronary angiogram or coronary CT angiogram within 5 years
    • Non-obstructive CAD defined as 0 to 49% diameter reduction of a major epicardial vessel or a FFR>0.80
  • Primary Exclusion
    • History of noncompliance (with medical therapy, protocol, or follow-up).
    • History of non-ischemic dilated or hypertrophic cardiomyopathy.
    • Documented ACS within previous 30 days.
    • LVEF <40%, NYHA HF class III-IV, or hospitalization for HFrEF within 180 days.
  • Site
    • Austin (Faraz Kureshi, MD)

CADFEM

  • Patient Population
    • Women with symptoms of significant coronary artery disease who are scheduled to undergo coronary angiography
  • Primary Inclusion
    • Symptoms suggestive of obstructive CAD
    • Scheduled to undergo cardiac catheterization with coronary angiography
  • Primary Exclusion
    • Suspected history of or acute myocardial infarction (AMI) at current presentation
    • Previous diagnostic coronary angiography, prior coronary artery bypass grafting (CABG) or previous coronary intervention (PCI)
    • Prior heart valve replacement 
    • Previous sustained or paroxysmal atrial or ventricular arrhythmia
  • Site
    • Austin, Round Rock and San Marcos (Roger Gammon, MD)