Clinical Trials & Research

The Cardiovascular Clinical Research program at VCS allows us to offer developing treatment options to our patients. Clinical Research Studies help pave the way for these new treatments to be made available to all patients, and advances medical knowledge in the field of Cardiovascular disease.

Each Research Study at VCS is led by one of our physicians, who serves as the Principal Investigator (PI) at our study site. Other VCS physicians may also participate in the research study as sub-investigators. Our patients are seen and cared for by a research physician while they are enrolled in a clinical study.

Participant Safety and Confidentiality

All Clinical Research Studies are actively monitored by a number of regulatory groups including the Food and Drug Administration (FDA) and local or regional Independent Review Boards (IRBs). Studies are conducted using strict protocols which define the criteria for participant selection, and detail exactly how the study is to be carried out from beginning to end. All staff who are involved in the conduct of the study protocol, including physicians and Research Coordinators, must complete study-specific training. The goal is to minimize risk and maximize safety for our study participants.

Participant identity is protected both by regulations of HIPAA (Health Insurance Portability and Accountability Act), and by the study protocols. Study participants are identified only by a study ID number which may also include their initials. The extent to which your medical information is used in the study will be explained to you in detail before you consent to participate.

For more information about participating in Clinical Research Studies, please visit the Center for Information & Study on Clinical Research Participation (CISCRP) website: www.ciscrp.org/

Participating in a Clinical Study at VCS

Your physician may recommend that you be considered for a clinical study based on your medical condition, need, and/or history. However, the decision to participate in a Clinical Research Study is an important and personal one. Our Clinical Research Coordinators (RCs) are here to help you in every part of the Research Study process, starting with your informed consent. They will give you all the information about the study that you need to make this decision, and will make sure all your questions are answered to your satisfaction. If you choose to participate, our RC's will coordinate your participation throughout the entire Clinical Study process, from helping to set up your study-related appointments to keeping you informed of any new pertinent study information. Your Research Coordinator serves as your partner and advocate in a clinical study at VCS.

For more information about Clinical Research and the current studies at VCS, please contact:

Studies Which Are Currently Enrolling Participants At VCS

Study Indication Details
CONVERGE Convergent procedure for treatment of persistent Atrial fibrillation This research study will evaluate the safety and effectiveness of the convergent procedure compared to a catheter ablation procedure for the treatment of persistent Atrial Fibrillation (AFib). The convergent procedure uses radiofrequency energy to create lines on both the outside and the inside surface of the heart to interrupt the abnormal electrical pathways that cause A Fib. The catheter ablation procedure creates lines on the inside of the heart only. Patients will be randomly assigned to have either the convergent procedure OR the catheter ablation procedure. Follow-up visits for the study will be at 1-month, 3-months, 6-months, 12-months, and 18-months after the procedure. There will also be follow-up phone calls at 2, 3, 4, and 5 years after your procedure.
AdaptResponse Patients who need a CRT device implanted A CRT device is a small electronic device that provides cardiac resynchronization therapy (CRT) to help the two lower chambers of the heart to beat in sync with each other, and pump blood more efficiently to relieve the symptoms of heart failure. This study will compare a specific CRT programming feature (called aCRT) with standard CRT programming to see if one is better than the other. Patients will be randomly assigned to have the aCRT programming feature turned on or off. Patients who enroll in the study will have a study visit before the device is implanted, information from the implant procedure will be collected for the study, and the assignment to aCRT on or off will occur within 7 days after the device is implanted. Study follow-up visits in the doctor’s office will be done at 3 and 6 months after the device is implanted, and every 6 months after that until the study closes. Study follow-up visits may last from 30 months (2½ years) to 66 months (5½ years) after the CRT device is implanted.

Studies Which Are Ongoing, But Not Currently Enrolling

Study Indication Details
CAMELLIA Patients who are obese or overweight and are at increased risk of heart disease or stroke. The main purpose of this research study is to assess whether lorcaserin HCl (brand name BELVIQ®) affects the risk of developing cardiovascular diseases in men and women at higher risk of developing these diseases. This study will also compare lorcaserin HCl with a placebo to see if taking lorcaserin HCl is better than taking a placebo. Patients who participate in the study will be randomly assigned to take either the study drug or the placebo. Participation in the study will last for five years.
COBRA PzF Shield Patients who need a stent placed to treat a blockage in their coronary artery. The purpose of this study is to determine the safety and effectiveness of an investigational stent that may be used to treat a blockage in the coronary artery. This particular stent is coated with a thin layer of a polymer and may make the stent less likely to develop clots and can reduce inflammation. Follow-up visits for this study will be at 30 days, 6 months, 9 months, and 1 year after treatment with the stent. After that, the study staff will call you on the telephone once a year for 4 more years to find out how you are doing.
Hybrid MAZE Atrial fibrillation An observational data-collection study to evaluate the safety and efficacy of the combined epicardial / endocardial ablation procedure for the treatment of patients with atrial fibrillation (AFIB).
Optimum ICDs for Ventricular arrhythmias. An ongoing registry of patients who have a specifically programmed ICD (implantable cardioverter defibrillator) to monitor shocks delivered for life-threatening ventricular arrhythmias. Follow-up visits are every 6 months.
Quad Pas Heart Failure with the need for cardiac resynchronization therapy (CRT) The purpose of this study is to evaluate the performance of a quadrapolar implantable cardioverter-defibrillator (CRT-D) device system for cardiac resynchronization therapy over the course of 5 years. The device has received FDA approval, this study is to collect long-term follow-up data. There will be study follow-up visits every 6 months for 5 years.
NAVIGATE X4 Patients who need a CRT-D device implanted for treatment of heart failure. A CRT-D device is a type of pacemaker that provides cardiac resynchronization therapy (CRT). This therapy helps the heart pump blood more efficiently, and can improve the symptoms of heart failure. The CRT-D device also has the capability to shock the heart out of life-threatening rhythms if needed. This research study will evaluate the performance and effectiveness of 2 investigational leads that are used with the CRT-D device. Patients enrolled in this study will have a study visit before their device implant procedure, and at 3 months after the procedure. Data for the study will also be collected during the implant procedure and before discharge from the hospital, and at regular/routine doctor visits every 6 months for 5 years after the device is implanted.
S-ICD PAS Patients who are at risk of sudden cardiac death and need an implantable cardiac defibrillator (ICD). An ICD delivers a shock to restore the hearts natural rhythm in case of sudden cardiac arrest. This study will evaluate the long-term reliability and performance of an FDA-approved implantable defibrillator called the S-ICD® System. This is a recently approved type of ICD which uses a wire placed under the skin that does not touch the heart, to monitor the heart rhythm and deliver the shock if the normal heart rhythm suddenly stops. Traditional implantable defibrillators use wires that are inserted through blood vessels and connected to the inside of the heart to monitor the heart rhythm and deliver the shock if needed.

 

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