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 Name: TAP-CHF

Overview:  TAP-CHF is a 2 phase study. Patients must have atrial fibrillation with heart failure (preserved ejection fraction) with at least one HF hospitalization in the past year or one or more documented HF events. Phase 1 will examine rhythm control using an initial catheter ablation strategy versus an initial antiarrhythmic drug (AAD) therapy strategy (50% chance of being in either group). Phase 2 will examine the strategy of optimizing heart failure (HF) therapy with and without wireless pulmonary artery pressure hemodynamic monitoring (CardioMEMs device). Phase 2 enrollees will have atrial fibrillation with HFpEF, prior HF hospitalization and class III heart failure, and are in persistent or recurrent HF despite rhythm control treatment in Phase 1.

Goal of Study: The goal of the study is to determine the time to the first of heart failure hospitalization or cardiovascular mortality during each phase. Event rates, safety and efficacy endpoints will be assessed with each strategy to assess support for a future trial.

Study Name: Target BP1

Overview: The TARGET BP I Trial is a randomized trial for patients with high blood pressure on medication comparing renal denervation  performed using a Peregrine System Kit in the treatment group to the control group (without renal denervation Рno alcohol infusion). Subjects will be selected with a 50/50 chance for either treatment.

Goal of the study: The purpose of the study is to evaluate the change in average 24-hour outpatient systolic blood pressure from start of participation to 3 months post-procedure.

Study Name: Alleviate HF

Overview: The Alleviate HF study is a randomized investigational device exemption (IDE) pivotal study. The purpose of the study is to determine the safety and effectiveness of a patient management system to assign risk levels to patients. All patients are implanted with a loop recorder called the Reveal LINQ to guide patient care in subjects with NYHA class II and III heart failure. Half of patients will be actively managed (this is randomly assigned) and the other half will not (control group). After 13 months participation, both groups will be monitored using the patient management information from the loop recorder.

Goal of the study: The purpose of the study is to determine the safety and effectiveness of this patient management pathway for remote heart failure management.

 

Study Name: PROACTIVE HF

Overview: The PROACTVE HF Study uses the Cordella PA Sensor System (CorPASS), which is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to SDCA for assessment and patient-centered heart failure management.

Goal of the study: All patient in the study will receive a device. The objective of the study is to evaluate whether use of the device leads to reduced heart failure hospitalizations and other emergent heart failure visits as well as mortality.

Study Name: 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 ‚Äď 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 Name: NODE 303

Overview: Node 303 is a study to evaluate the safety of etripamil NS  (nasal spray) in patients with Paroxysmal Supraventricular Tachycardia (PSVT). Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer the study drug called Etripamil NS if vagal maneuver is ineffective to manage episodes of PSVT. All patients will receive active study drug.

Goal of the Study: The goal of the study is to determine the safety and efficacy of Etripamil NS 70 mg for the patient-administered treatment of acute episodes of PSVT outside of the clinical setting.

Study Name: SUMMIT

Overview: SUMMIT is randomized Phase 3 study comparing the efficacy and safety of a drug called Tirzepatide (versus placebo) in patients with heart failure with preserved ejection fraction and obesity. Tirzepatide is approved in the US for other indications.

Goal of the Study: The main purpose of this study is to assess the efficacy and safety of Tirzepatide in participants with heart failure with preserved ejection fraction and obesity.

Study Name: ACURATE IDE

Overview: ACURATE IDE is a safety and effectiveness study of the ACURATE valve for transcatheter aortic valve replacement.

Goal of the Study: The goal of the study is to evaluate the safety and effectiveness of the ACURATE transfemoral aortic valve system for transcatheter aortic valve replacement in subjects with severe native aortic stenosis who are indicated for TAVR.

 

Study Name: CATALYST

Overview: CATALYST is a trial comparing subjects with non-valvular atrial fibrillation who are randomized 1:1 to either the Amulet left atrial appendage occlusion device (“Device Group”) and a commercially available NOAC (novel oral anticoagulant) medication (“Control Group”). The choice of NOAC in the control group will be left to the patient‚Äôs cardiologist.

Goal of the Study: The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular atrial fibrillation at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

Study Name: RELIEVE HF

Overview: The RELIEVE HF study goal is to demonstrate reducing lung congestion symptoms in advanced heart failure using the V-Wave Interatrial Shunt System. This clinical study will be randomizing patients to either a shunt treatment arm or non-implant control arm.

Goal of the Study: The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with heart failure who are treated with guideline-directed drug and device therapies.