The comprehensive clinical research enterprise at Inova Schar Heart and Vascular

When Inova promotes having access to the latest clinical trials, it’s not just a talking point. With the support of Inova’s leadership, Inova Schar Heart and Vascular has built a comprehensive clinical research enterprise that spans many dimensions of cardiology and offers a menu of trials that rivals the nation’s elite heart centers.

Many forms of clinical research fall within Inova’s purview. For example, through industry trials, Inova’s team may provide early access to new technologies for our patients. Inova physicians also engage in discovery projects, designed to help researchers evaluate and understand a treatment mechanism or disease process.

“We’re part of groundbreaking research with novel technologies in both drug and device-based therapies, and we’re also helping to define where the science is headed today,” said Sumeet S. Mitter, MD, MSc, Director of Clinical Trials and Site-based Research at Inova Schar Heart and Vascular and Director of the Infiltrative and Restrictive Cardiomyopathy Center.

Here is a sample of the leading-edge trials Inova Schar Heart and Vascular teams are offering patients.

Preventive cardiology

Inova was selected as a site for the Ocean(a) PreEvent study sponsored by Amgen under principal investigator Jared Spitz, MD. This study evaluates the effect of a siRNA drug, olpasiran, (compared to placebo) in people with elevation in Lp(a) who are at high risk for a first cardiac event based on the risk of having a heart attack, needing urgent intervention for coronary artery blockages or dying from heart disease. Currently, no drugs exist that specifically lower Lp(a). Olpasiran is one of a number of drugs currently being tested to see how well they lower Lp(a). Ultimately, researchers hope this drug will help prevent recurrent heart attacks or death from heart disease.

Inova has recently been activated for the ACT-EARLY study sponsored by BridgeBio under principal investigator Sumeet S. Mitter, MD, MSc.  That study evaluates the use of acoramidis, a TTR stabilizer, to prevent the onset of hereditary transthyretin amyloid cardiomyopathy and/or neuropathy among those who carry a genetic variant for the disorder but no manifest disease yet.

Advanced heart failure

Continuing the expansion of the amyloid investigational therapeutics portfolio, in 2026, will be participating in a trial for another TTR amyloid depleting agent coramitug (CLEOPATTRA, sponsor NovoNordisk) and another drug for TTR suppression nucresiran (TRITON-CM, sponsor Alnylam) to reduce mortality and CV events in those with documented TTR cardiac amyloidosis.  Both studies will be led by Sumeet S. Mitter, MD, MSc at Inova.

Under the leadership of Palak Shah, MD, MS, Inova is one of 26 medical centers across the U.S. evaluating the BrioVAD System, a new LVAD using advanced technology in a smaller lightweight pump by BrioHealth Solutions. Following the company’s successful completion of the Safety Phase, the Pivotal Phase trial is now underway. The objective of the INNOVATE Trial is to evaluate the safety and efficacy of the BrioVAD System when used for the treatment of advanced, refractory, left ventricular heart failure. The trial will look at quality of life and also determine if patients living with the BrioVAD System spend less time in the hospital. The BrioVAD System features a novel, fully magnetically levitated blood pump engineered for enhanced cardiac support, along with an innovative driveline design. The system is also distinguished by having only two external components that the patient needs to carry while ambulatory.

Electrophysiology

In September 2025, Inova began enrollment in the ELEVATE HFpEF trial, which is investigating whether increasing resting heart rate by pacemaker implantation may improve symptoms of shortness of breath and fatigue in patients with heart failure and a normal ejection fraction, a condition with few effective treatment options. 

Brett Atwater, MD, D’Aniello Chair, Atrial Fibrillation and Section Chief of Electrophysiology at Inova Schar Heart and Vascular, is the international co-principal investigator, and Inova Schar Heart and Vascular is the only recruiting site in the Washington, DC, metropolitan area. Inova’s goal is to enroll 15 to 20 patients in the next two to three years.

“This study has the potential to change the way that the field treats HFpEF,” Dr. Atwater said. “It demonstrates our dedication to pushing the application of technologies in order to help patients who currently don’t have many options.”

Horizon 360

In 2026, Inova Schar Heart and Vascular will begin enrollment in the Horizon 360 clinical trial, sponsored by Medtronic. This trial will evaluate the safety and efficacy of the novel Sphere 360 pulse field ablation catheter and the Affera mapping system for treatment of symptomatic paroxysmal AFib.

The unique catheter design may improve the durability of AFib ablation, reducing the need for repeat procedures, while simultaneously reducing procedural risks compared to current generation pulse field ablation products. Inova was selected as one of only 20 U.S. sites to provide early access to the Sphere 360 catheter through participation in the Horizon 360 trial.

Bachmann bundle atrial pacing

Inova’s EP teams have been engaging in a research project that aims to determine what mechanisms may be responsible for the observed reductions in AFib when pacing is placed in the Bachmann bundle rather than the conventional right atrial appendage. In 2026, Inova Schar Heart and Vascular plans to begin leading a multicenter randomized controlled trial that will evaluate those two lead positions and study the frequency of AFib events among patients who are randomly allocated to either position.

Heart block analysis

Inova is conducting proteomic analysis of patients with atrioventricular conduction block orsinus node dysfunction, comparing the protein expression levels for patients who have these two different indications for pacemaker implantation. The project’s goal is to better understand the mechanisms that lead to heart block, which may pave the way for researchers to identify pharmacologic targets for treatment.

Interventional cardiology

In 2026, Inova will be building on its earlier research with the AGENT™ Drug-Coated Balloon by Boston Scientific, a device to treat in-stent restenosis, in a trial, evaluating the drug-coated balloon’s efficacy in:

• Native, unstented vessels
• Small vessels (less than 2.75 mm)
• Long vessels (longer than 20 mm)
• Branch vessels

“We will be one of the sites participating in this landmark clinical trial, in which drug-coated balloons are compared to drug-balloon stents,” said Behnam Tehrani, MD, Co-Director of Cardiac Catheterization Laboratories for Inova Fairfax Medical Campus.

In 2023, Inova Schar Heart and Vascular at Inova Fairfax Hospital was the only hospital in the Washington, DC, metropolitan area selected to participate in the clinical trial used to demonstrate the effectiveness of the AGENT™ Drug-Coated Balloon.

Ultrasound-based renal denervation is a promising therapy for high-risk patients with difficult-to-control high blood pressure. It is available for patients whose blood pressure remains high despite lifestyle changes and who already take three or more blood pressure medications. Inova Schar Heart and Vascular will participate in a number of registries as the team continues to perform these procedures for patients.

“For any disease state within cardiovascular research right now, we’re likely part of a trial related to that disease,” Dr. Mitter said. “We have the experts, the resources and the leadership that enable us to double down and look ahead to where the field of cardiovascular research is headed.”