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Current Studies

If you are interested in participating in or learning more about our research program, please ask your cardiologist or call 303-744-1065 and ask for the research department.

Study Type: CHOLESTEROL/LIPID LOWERING – VESALIUS

Overview: This study will evaluate whether administration of Evolocumab (Repatha) 140 mg injection every 2 weeks versus placebo in patients at high risk for cardiovascular events without a history of prior myocardial infarction or stroke. About 12,000 patients will be randomized 1:1 to receive either Evolocumab (Repatha) or placebo.

Goal of the study: To reduce the risk of coronary heart disease (CHD) death, myocardial infarction (MI), stroke, and ischemia-driven arterial revascularization in adults at high risk of cardiovascular events without prior MI or stroke.

Study Type: HYPERKALEMIA– Diamond

Overview: This study will evaluate whether the administration of Patiromer 1 packet/day versus placebo can be used to treat hyperkalemia in high-risk heart failure patients with reduced ejection fraction. About 2,388 patients will be randomized 1:1 to receive either Patiromer or placebo.

Goal of the study: The ability of Patiromer to treat hyperkalemia will allow better adherence to heart failure guidelines which will lead to a decrease in the occurrence of cardiovascular death and hospitalization compared to placebo treatment.

Study Type: Paroxysmal Supraventricular Tachycardia – NODE 301

Overview: A study to evaluated the safety of Entripamil Nasal Spray for the termination of spontaneous episodes of paroxysmal supraventricular tachycardia.

Goal of the study: The primary objective of this study is to determine whether entripamil nasal spray 70mg self-administered by patients is superior to placebo at terminating episodes of paroxysmal supraventricular tachycardia in an outpatient setting.

Study Type: Acute Coronary Syndrome – AEGIS II

Overview: A double-blind, randomized, placebo-controlled study to investigate the efficacy of safety of CSL112 in subjects with an acute coronary syndrome.

Goal of the study: The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of cardiovascular death, myocardial infarction or stroke from the time of randomization through 90 days in subjects with an acute coronary syndrome.  Subjects receive 4 weekly 2 hour infusions of CSL112 or placebo.

Study Type: PFO and Stroke – AMPLATZER PFO Occluder Post Approval Study

Overview: The AMPLATZER PFO Occluder device is implanted in all subjects who enrolled in the study.

Goal of the study: This clinical study is intended to demonstrate the safety and effectiveness of the AMPLATZER PFO Occluder, in a post-approval setting, in patients with a PFO who have had a cryptogenic stroke confirmed by a study neurologist.

Study Type: GuideHF-CardioMEMS

Overview: This study is intended to demonstrate the effectiveness of the CardioMEMS HF Systems device in patients with a New York Heart Association (NYHA) Class II, III or IV Heart Failure with either an elevated NT-proBNP (or BNP) and/or a prior Heart Failure hospitalization within the last 12 months.  All subjects will receive a CardioMEMS HF Systems device and will either be randomized in a 1:1 ratio into either a treatment group or a control group.

Goal of the study: CardioMEMS is currently approved NYHA Class III patients.  The GuideHF study will demonstrate the recommended indication for patients with other NYHA Class designations to have a benefit from the device.  Benefits including but not limited to reduction in Heart Failure hospitalizations, cost savings, and improved preventative care.

Study Type: Meteoric HF

Overview: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecantiv Mecarbil on Exercise Capacity in Subjects with Heart Failure with Reduced Ejection Fraction and Decrease Exercise Tolerance.

Goal of the Study: The primary objective is to evaluate the effect of treatment with omecamtiv mecarbil (OM) compared with placebo on exercise capacity as determined by cardiopulmonary exercise (CPET) following 20 weeks of treatment with OM or placebo.

Study Type: Orion-4

Overview: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease. This trial is called HPS-4/Timi 65/ORION – 4.

Goal of the Study: It is testing whether a medicine called Inclisiran, which is given subcutaneous injection every six months, can safely help to prevent heart attacks and strokes in patients who are known to have diseased arteries.

Study Type: Antitachycardia Pacing: Appraise ATP

Overview: ICD study, Shock alone vs. Antitachycardia pacing + shock, to assess equivalency.

Goal of the Study: The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy. The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency.

Study Type: Left Atrial Appendage Occluder - ASAP-TOO

Overview: The study is designed to collect data for the WATCHMAN LAA Closure Device, in subjects with non-valvular AF who are unable to take oral anticoagulants, even for a short period of time.

Goal of the Study: The primary objective of this study is to establish the safety and effectiveness of the WATCHMANTM Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke. The device is intended to reduce the risk of thromboembolic ischemic stroke and systemic embolism.

Study Type: PFO - Gore PAS 18-01

Overview: To prove acceptable performance of the GSO device in patients treated with PFO closure plus antiplatelet medical management compared to performance goals derived from REDUCE study results.

Goal of the Study: The purpose of the GORE® CARDIOFORM Septal Occluder (GSO device) post-approval study is to assess the safety and effectiveness of GSO device as observed in the REDUCE pivotal IDE study, and to evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Study Type: Left Atrial Appendage Occluder - Option

Overview: To compare LAA closure with the WATCHMAN FLX Device to Oral Anticoagulant treatment following percutaneous catheter ablation for high-risk patients with non-valvular AF.

Goal of the Study: The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high-risk patients with non-valvular atrial fibrillation.

Study Type: Paroxysmal atrial fibrillation - TactFlex

Overview: Safety and Effectiveness study of the TactiFlex™ used in ablation procedure for the treatment of drug-refractory, symptomatic Paroxysmal atrial fibrillation (AF)

Goal of the Study: The primary objective of the TactiFlex PAF IDE clinical trial is to demonstrate that ablation with the TactiFlex™ Ablation Catheter, Sensor-Enabled™ (TactiFlex SE), in conjunction with a compatible RF generator and three-dimensional mapping system, is safe and effective for the treatment of drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF) when following standard electrophysiology mapping and radiofrequency (RF) ablation procedures.

Study Type: Trans Aortic Valve Replacement (TAVR) – Protected TAVR

Overview: Stroke Protection with Sentinel during Trans Aortic Valve Replacement (TAVR)

Goal of the Study: The objective of this study is to demonstrate that the use of the Sentinel® Cerebral Protection System significantly reduces the risk of periprocedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

Study Type: Heart Failure – Paraglide HF

Overview: Entresto vs. Valsartan on changes in NT-proBNP (lab) and outcomes, safety, and tolerability in patients who have Heart Failure with preserved Ejection Fraction and with Acute Decompensated Heart Failure who have been stabilized during hospitalization and initiated in-hospital or within 30 days post-discharge.

Goal of the Study: To demonstrate the effect of sacubitril/valsartan (Entresto) vs. valsartan on time-averaged proportional change in NT-proBNP (lab) from baseline to Weeks 4 and 8 in patients with Heart Failure with preserved Ejection Fraction who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or within 30 days post-discharge.