Clinical Research

• ALLAY HFrEF - Evaluates the safety and effectiveness of the ALV1 System for heart failure with reduced ejection fraction.
• ALLIANCE AVIV - Tests the SAPIEN X4 Transcatheter Heart Valve for patients with a failing aortic bioprosthetic valve.
• AURORA-HFpEF - Assesses the safety of MYK-224, an investigational drug for heart failure with preserved ejection fraction.
• CARVTOP ICD - Compares outcomes of carvedilol versus metoprolol succinate in patients with implantable cardioverter-defibrillators and heart failure.
• CHAMPION AF - Determines if Left Atrial Appendage closure with the WATCHMAN FLX™ Device is an alternative to blood thinners for patients with atrial fibrillation.
• CLASP II TR - Evaluates the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System for tricuspid regurgitation.
• EARLY TAVR - Studies whether aortic valve replacement is helpful for patients who have a narrowing of the aortic heart valve in which calcium has attached to the valve surface.
• EMPOWER - Assessment of the Carillon Mitral Contour System® in Treating Heart Failure with Functional Mitral Regurgitation
• FIRE1 - Determines if the NORM™ System can be successfully and safely implanted, and be used to help improve the management of heart failure.
• LEVEL - Assesses whether levosimendan improves the distance participants with heart failure with preserved ejection fraction can walk in 6 minutes.
• PROGRESS - Evaluates SAPIEN 3™, SAPIEN 3 Ultra™, and SAPIEN 3 Ultra RESILIA™ Transcatheter Heart Valve for calcific aortic stenosis treatment.
• REBALANCE HF - Evaluates the safety and benefits of single‑side ablation of the greater splanchnic nerve (GSN) in people with HFpEF.
• REFORM HF - Tests the AquaPass System in patients with decompensated heart failure and persistent fluid overload.
• RELIEVE HF - Evaluates the safety of the V-Wave shunt and how well it works in helping heart failure patients.
• REPAIR MR - Evaluates the use of the MitraClipTM system in patients with severe primary mitral regurgitation who are at moderate surgical risk.
• SYNCHRONICITY - Studies the safety and effectiveness of left bundle branch area pacing in patients with heart failure.

• ARTEMIS - Determine if ravulizumab is safe and works to protect Chronic Kidney Disease patients from Acute Kidney Injury after open-heart surgery.

• Food Allergy Biobank - Studies proteins that cause allergic reactions and immune molecules and cells in blood to develop better detection, diagnostic or therapeutic agents for food allergies.
• RAPID - Collects information on patients aged 12+, who are starting treatment with dupilumab (DUPIXENT®) for asthma to better understand patient characteristics, use, effectiveness, and safety.
• Home Peanut Oral Immunotherapy - Determines the safety and satisfaction of up-dosing encounters for peanut oral immunotherapy.
• IgE Mediated Food Allergy - Tracks choice of food allergy management in individuals over the age of 1 with IgE mediated food allergy.
• Short Versus Detailed After Visit Summaries - Compares a short, bulleted After Visit Summary (AVS) with disease specific instructions to a longer, prose AVS with background disease state information.
• DACAT - A study to improve cephalosporin allergy testing and to determine what causes cephalosporin allergy.
• Telemedicine for Penicillin Allergy Testing in Pregnancy - A study to improve evaluating telemedicine-facilitated amoxicillin challenges in obstetric offices for pregnant patients with low-risk penicillin allergy.
• Challenges to Penicillin-Based Antibiotics in the ICU - Tracks all patients undergoing direct challenges to penicillin in the ICU setting.

• Prevalence of Humoral Dysfunction - Determine if patients with COPD and frequent exacerbations who have abnormal immune function experience less exacerbations on therapy with Cuvitru.
• Mepolizumab - Understand how well the medication mepolizumab (NUCALA) is working in routine medical practice to treat severe asthma patients who have an eosinophilic phenotype (SA-EP).
• AIM4 - Determine which regimen is more effective: taking dupilumab with an inhaled asthma study drug or only taking a higher dose of the inhaled asthma study drug. 

• AROMA - Understand the characteristics of patients who receive DUPIXENT for Chronic Rhinosinusitis with Nasal Polyposis and the treatment patterns.

Clinical research translates basic science and discoveries into safe and effective tests, drugs, devices and procedures, eligible for approval by the U.S. Food and Drug Administration (FDA). Clinical trials are carefully designed and monitored studies intended to test and evaluate investigational drugs and treatment plans.

Many participants are patients whose own illnesses are not responding to standard treatment, and who hope that the study treatment – possibly an investigational drug, a device, or a combination of drugs or devices – will work better than standard therapy.

Other participants are healthy people who want to contribute to medical science and to help doctors and researchers find better ways to treat others’ illnesses.

Researchers follow strict ethical and scientific principles to ensure that patients are protected and that the results produced are valid. The study’s sponsor – a drug or device company – will draft a plan of how the study will proceed. This plan, or protocol, specifies how many individuals will be enrolled, how much drug will be used and when, what medical tests will be provided, and so on.

Evaluating new treatments involves some risks. Using a small group of volunteers, Phase I trials determine the best dosing and identify side effects. After a drug is shown to be safe and well-tolerated, Phase II and Phase III trials provide treatment to a larger numbers of patients with a specific disease. Side effects can vary, with dangerous complications possible.

To ensure that participants are not be exposed to unreasonable or unethical risks, every protocol is reviewed and approved by the sponsoring organization as well as an Institutional Review Board (IRB), which consists of health professionals, clergy and other community members. At Rochester General, the Office of Human Research Protection fulfills the IRB role.

Your doctor’s referral is not necessary, but anyone seriously considering a trial is urged to talk with his or her doctor and family about the potential benefits and risks. In order to participate, you will be evaluated by the medical staff conducting the study to determine whether you meet the medical criteria.

If you’re approved to join a trial, you should continue seeing your regular physician. Trial coordinators will consult with your doctor about how the study’s therapies are impacting you.

In most cases, the drugs and devices used, and any procedures for the study such as blood work, urine samples, x-rays and travel expenses are provided free to participants. Other costs unrelated to the trial may be covered by the patient’s insurance company or Medicare. Be sure to get a full accounting of costs before committing to a trial.

Each phase of clinical research is designed to gather specific information about the study drug, device or treatment.

Phase I

A Phase I trial is designed to determine the best dose of the investigational drug and to identify any potential side effects. Because a Phase I study represents the first time an investigational drug or therapy is being used on humans, the risks can be significant. Such trials typically involve a small number of volunteers.

Phase II

Begun after an investigational treatment is initially shown to be safe and well-tolerated, aPhase II trial studies how well the treatment works, usually in a larger group of patients. Early- and late-stage Phase II trials may be called Phase IIA and Phase IIB.

Phase III

Phase III trials examine how well the drug or therapy works in hundreds or many thousands of patients. In this phase, the study drug may be compared to an existing standard treatment. Early- and late-stage Phase II trials may be called Phase IIIA and Phase IIIB.

Phase IV

After a drug has been approved by the U.S. Food and Drug Administration and marketed, Phase IV trials – typically involving a large number of participants – may evaluate new uses of existing therapies or be used to detect side effects that did not appear during Phase III.

The National Institutes of Health guides potential participants in deciding whether to participate, and encourages that individuals ask the following questions:

• What is the purpose of the trial?
• What kind of tests and treatments are involved?
• What is likely to happen in my case with, and without, this new research treatment?
• What are alternative treatment options and their advantages and disadvantages?
• How might this trial affect my daily life?
• What side effects might I expect from the study?
• How long will the trial last?
• Will hospitalization be required?
• If I were harmed as a result of the trail, what treatment would I be entitled to
• What type of long-term follow-up care is part of this study? 

The following organizations provide additional information:

• Food and Drug Administration Consumer Health Information
• The Center for Information and Study on Clinical Research Participation (1-888-CISCRP3)
• ClinicalTrials.gov – a registry of federally and privately supported clinical trials currently being conducted in the United States and around the world
• VeritasMedicine.com – the source for some of the above questions and answers