Clinical Research

Actively Recruiting

CREST

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

General Inclusion Criteria:

  1. Patient is ≥35 years old.
  2. Stenosis ≥70% by catheter angiography (NASCET Criteria) OR by DUS with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following:
    • an end diastolic velocity ≥100 cm/s, or
    • internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or
    • CTA with ≥ 70% stenosis, or
    • MRA with ≥ 70% stenosis.
  3. No medical history of stroke or TIA

SOPRANO

Macitentan vs. placebo for LVAD patients who develop pulmonary hypertension (randomized 1:1)

General Inclusion Criteria:

  1. Written informed consent prior to initiation of any study-mandated procedure.
  2. Males or females ≥ 18 years of age.
  3. Surgical implantation of LVAD (e.g., HeartMate II or HeartWare) within 45 days prior to Randomization.
  4. Hemodynamic evidence of PH on Baseline right heart catheterization (RHC). Baseline RHC is defined as the last hemodynamic measurements after LVAD implantation and prior to Screening. Baseline RHC can be obtained via either routine RHC or pulmonary artery catheter. PH is defined as:
    • Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
    • Pulmonary artery wedge pressure (PAWP) ≤ 18 mmHg
  5. PVR > 3 Wood units.
  6. Stabilization of the patient after removal of the pulmonary artery catheter, defined as:
    • No LVAD pump speed/flow rate changes for 48 h to Screening and
    • Stable dose of diuretics for 48 h prior to Screening and
    • No intravenous (i.v.) inotropes or vasopressors for 48 h prior to Screening and
    • Patient able to ambulate 48 h prior to Screening.
  7. A woman of childbearing potential is eligible if she has:
    • A negative serum pregnancy test at Screening and a negative serum pregnancy test at Baseline.
    • Agreed to undertake monthly serum pregnancy tests during the study and up to 30 days after study drug discontinuation.
    • Agreed to use one of the methods of contraception / follow the contraception scheme described in Section 4.5 from Screening up to at least 30 days after study treatment discontinuation.

EMPEROR

Jardiance (empagliflozin) vs. placebo in patients with congestive heart failure with preserved ejection fraction (> 40%) (randomized 1:1)

General Inclusion Criteria:

  1. Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in NYHA HF class II-IV
  2. Chronic HF with preserved EF defined as LVEF > 40 % per local reading
  3. Elevated NT-proBNP > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analyzed at the Central laboratory at Visit 1
  4. Patients must have at least one of the following evidence of HF:
    • Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1, OR
    • Documented hospitalization for HF (HHF) within 12 months prior to Visit 1
  5. Oral diuretics, if prescribed to patient according to local guideline and discretion of the Investigator, should be stable for at least 1 week prior to Visit 2 (Randomization)
    eGFR (CKD-EPI)cr ≥ 20 mL/min/1.73m2 at Visit 1

GUIDE HF

CardioMEMS for Class II-IV CHF patients, all patients are implanted but we will be blinded to data for the first year on half of the patients

General Inclusion Criteria:

  1. Diagnosis and treatment for HF (regardless of LVEF) for > 90 days prior to the date of consent:
    • Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current AHA/American College of Cardiology (ACC)guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
  2. GUIDE-HF Randomized Arm Only: NYHA Class III or IV HF symptoms documented within 30 days prior to consent.
  3. GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
  4. HFH within 12 months prior to consent and/or elevated NT-proBNP (or BNP) within 30 days priorto consent defined as:
    • Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
    • Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
    • Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will becorrected for BMI using a 4% reduction per BMI unit over 25 kg/m2
  5. ≥ 18 years of age
  6. Chest circumference of < 65 inches, if BMI is > 35 kg/m2
  7. Written informed consent obtained from subject
  8. Willing and able to upload PA pressure information and comply with the follow-up requirements

HARP

  1. 3 vessel OCT & Cardiac MRI in MINOCA patients & randomized stress management study for MINOCA & MI CAD patients
  2. General Inclusion Criteria
  3. Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms
  4. Objective evidence of MI (either or both of the following):
    • Elevation of troponin to above the laboratory upper limit of normal (ULN)
    • ST segment elevation of ≥1mm on 2 contiguous ECG leads
  5. Willing to provide informed consent and comply with all aspects of the protocol
  6. Age ≥ 21 years
  7. Female sex

PREEMPT HF

Evaluation of the Heart Logic sensor in patients with ICD or CRT-D

General Inclusion Criteria:

  1. Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws.
  2. Subject has a documented diagnosis of heart failure.
  3. Subject has a Boston Scientific CRT-D or ICD device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON.
  4. Subject has an active bipolar RV lead implant.
  5. Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled.

XL PAD

Peripheral Arterial Disease Interventions and Outcomes Registry

General Inclusion Criteria:

  1. Patients with symptomatic PAD who undergo an endovascular treatment of PAD in the SFA distribution and below- the knee (BTK) distribution will be eligible to be included in the registry. The registry will aim to capture data on all consecutive patients undergoing femoro-popliteal and below the knee percutaneous interventions.

SHORE

Surveillance Heart Care Outcomes Registry

General Inclusion Criteria:

  1. Heart transplant recipients who are selected by their health care provider to be managed with HeartCare.
  2. Patients who are selected by their health care provider to be managed following the Heart Routine Testing Schedule (HARTS) or a derivative of the schedule that has been defined by the provider.
  3. Patients who provide written informed consent.
  4. Patients who have HeartCare initiated within 30 days of signing the informed consent form.

PFO PAS

Post-approval registry for Amplatzer PFO closure device

General Inclusion Criteria:

  1. Subjects with a PFO who have had an ischemic stroke within the last 547 days
  2. Patients who have undergone investigation by a neurologist to exclude known causes of ischemic stroke, and have therefore been determined to have had a cryptogenic stroke
  3. CVA ssessed by a neurologist within the last 547 days, with stroke defined as follows:
    • acute focal neurological deficit, presumed to be due to focal ischemia, and either
      1. symptoms persisting 24 hours or greater, or
      2. symptoms persisting less than 24 hours but associated with MR or CT findings of a new, neuroanatomically relevant, cerebral infarct.

Coming Soon

WARRIOR

Women’s Ischemia Trial to Reduce Events in  Non-Obstructive CAD

General Inclusion Criteria:

  1. Signs and symptoms of suspected ischemia prompting referral for further evaluation by cardiac catheterization, or coronary angiogram or coronary CT angiogram within 5 years from consent.
  2. Willing to provide written informed consent.
  3. Age ≥18 yrs.
  4. Non-obstructive CAD defined as 0 to 50% diameter reduction of a major epicardial vessel.

SHIELD II

Supporting Patients Undergoing High-Risk PCI Using a High-Flow  Percutaneous Left Ventricular Support Device

General inclusion Criteria:

  1. At least 18 years of age
  2. Subject is undergoing elective or urgent high-risk PCI procedure and is hemodynamically stable.
  3. Subject is indicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft.
  4. A heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option.
  5. Subject must provide written informed consent prior to any clinical investigation related procedure.

NODE 303

Evaluate safety of etripamil NS in patients with PSVT.

General inclusion Criteria:

  1. Has been diagnosed with PSVT by a medical professional, and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic SVT that includes the AV node as a critical part of reentrant circuit. See Section 6.4 for details on diagnostic criteria.
  2. Is at least 18 years of age;
  3. Signed NODE-303 written informed consent
  4. Women of child-bearing potential must be willing to use at least 1form of contraception during the trial, and must be willing to discontinue from the study should they become or plan to become pregnant
  5. Willing and able to comply with study procedures

TARGET

Renal denervation study

General Inclusion Criteria:

  1. Subject has provided written informed consent.
  2. Male or female subject, aged ≥18 and ≤80 years at time of enrollment.
  3. Subject is taking 2-5 antihypertensive medications (labeled for hypertension) at time of enrollment, and is willing to adhere to a stable (no change) medication regimen during the 4-week run-in period and the 3 months post-procedure.
  4. Investigator judges that the subject can be managed safely during the 4-week run-in period and 3 months post-procedure period without any changes to their current antihypertensive medication regimen.
  5. Female subjects of childbearing potential must agree to use acceptable methods of contraception (as defined in the protocol), from the time of informed consent through to the last follow-up visit.
  6. Subject agrees to have all study procedures performed and is able and willing to comply with all study follow-up visits and protocol requirements.

Research in followup/closed to enrollment

Takeda Study – A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events”, TAK-875_306.

St. Jude Medical – LAPTOP-HF – Randomized trial to evaluate whether using physician-directed, patient self-management system guided by left atrial pressure measurements, can improve outcomes in patients with heart failure.

Abbott – ACT 1- A Randomized, Controlled Trial to Demonstrate the Equivalence of Carotid artery Stenting using the Xact RX Carotid Stent System with the Emboshield Cerebral Protection System when Compared to Carotid Endarterectomy of Asymptomatic Extracranial Occlusive Disease.

Cordis – ELITE – A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER ELITE to the CYPHER Bx VELOCITY Sirolimus-Eluting Stent Systems.

Abbott – XIENCE V – XIENCETM V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study.

Medtronic – RESOLUTE – Clinical Evaluation of the Medtronic Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Native Lesions in Native Coronary Arteries with the Reference Vessel Diameter of 2.25mm to 4.2mm.

Abbott – MOBILITY – A Prospective, Non-Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Absolute ProTM Peripheral Self-Expanding Stent System in Subjects with Atherosclerotic De Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.

Medtronic – Complete SE SFA – The Medtronic Complete Self-Expanding (SE) SFA stent for the treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery

HCRI – DAPT – A Prospective, Multi-Center, Randomized, Double-Blind Trial to Assess the Effectiveness and Safety of 12 versus 30 months of Dual Antiplatelet Therapy (DAPT) in subjects undergoing Percutaneous Coronary Intervention (PCI) with Either Drug Eluting Stent (DES) or Bare Metal Stent (BMS) Placement for the Treatment of Coronary Artery Lesions”.

Eli Lilly – The Trilogy ACS Study – A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/ Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) who are Medically Managed.

Medtronic – EDUCATE – Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet agents and Thrombotic Events.

Roche – ALECARDIO – Cardiovascular outcomes study to evaluate the potential of Aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome event and type 2 diabetes mellitus.

CANOPY – Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy – Study to assess the performance outcone of the RX Acculink Stent system under commercial use in patients at standard risk for adverse events from CEA

MOMENTUM Study – A clinical trial to evaluate the safety and effectiveness of the ABSOLUTE PRO® peripheral self-expanding stent system and the ABSOLUTE PRO® LL peripheral self-expanding stent system in the treatment of subjects with atherosclerotic de novo or restenotic leasions in the native superficial femoral artery and/or native proximal popliteal artery.

PROMISE Trial – Prospective Multicenter Imaging Study for Evaluation of Chest Pain – Study to determine whether the information derived from an anatomic imaging strategy (CTA) as compared to a functional testing strategy will provide superior clinical outcome in pts with symptoms concerning for CAD

EUCLID (Examining Use of tiCagreLor In paD) Study – A study to compare ticagrelor (Brilinta) with clopidogrel (Plavix) treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (PAD).

ORBIT-AF II Study – Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. Study of patients 21 years of age or older with a new diagnosis of Atrial Fibrillation within the past 6 months and currently taking a novel oral anticoagulant that has been started within the past 3 months.

VOYAGER – Vascular Outcomes study of ASA along with Rivaroxaban in Endovascular or surgical limb Revascularization for peripheral artery disease (PAD)

SAFE – A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter in Arteries of the Superficial Femoral Artery (SFA)and Popliteal Artery (PA)

MITROCLIP – Ascension Seton heart valve clinic is the first site in Central Texas to participate in a groundbreaking study of the potential benefits of MitraClip®, a catheter-based, minimally invasive treatment option that can help patients with severe mitral regurgitation.

TWILIGHT – Ticagrelor with or without aspirin following percutaneous coronary intervention (randomized 1:1 at 3 months)

CLEAR – Bempedoic acid vs. placebo for statin intolerant patients with LDL >100

ENSITE PRECISION – Prospective, post-market observational study of the EnSite Precision Cardiac Mapping System

ABSORB III/IV – The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

CHAMP HF – Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction