Georgia Heart Institute and Northeast Georgia Health System (NGHS) have completed more than 100 clinical trials over the last 15 years, making us a leader in conducting clinical research in the field. We partner with pharmaceutical and medical device industry leaders, non-profit organizations, private foundations, and government agencies to offer our patients access to the latest, most innovative therapies available.
In addition to the physicians and surgeons who lead clinical trials, our program has a full research team including four dedicated and highly trained registered nurse research coordinator who manage the operations of all cardiology clinical trials. With backgrounds in critical care and cardiology, our research team oversees quality, provides clarity and answers to questions, while also ensuring the best experience possible for patients and referring providers.
With decades of research and clinical trials performed at NGHS, heart patients have already benefited from carotid stenting, robotic angioplasty, MRI compatible pacemakers and new medications for the treatment of cardiovascular disease.
Heart and Vascular Clinical Trials
Explore our current clinical trials for cardiology:
[Updated: 05/23/23]
Electrophysiology
Status:
Active, in follow-up
Description:
The AMPLATZER™ Amulet™ Left Atrial Appendage (LAA) Occluder Trial is designed to evaluate the safety and effectiveness of the Amulet device compared to the approved WATCHMAN LAA closure device in patients with non-valvular atrial fibrillation and at a high risk for bleeding. Eligible patients will be randomized to receive either the Amulet device or the WATCHMAN device.
Status:
Enrolling
Summary:
Pragmatic Randomized Clinical Trial of Early Dronedarone versus Usual Care to Change and Improve Outcomes in Persons with First-Detected Atrial Fibrillation.
Description:
The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected AF. All patients will be treated with guideline-recommended stroke prevention therapy according to the CHA2DS2-VASc score.
General Cardiology
Status:
Active, In follow-up
Summary:
A Cross-Sectional Study of Lipoprotein(a) Levels in Patients with Documented History of Atherosclerotic Cardiovascular Disease
Description:
This is a pre-screening cardiovascular outcome trial of patients with elevated Lipoprotein(a).
Status:
Enrolling
Summary:
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) – Outcomes Trial
Description:
The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
Status:
Enrolling
Summary:
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Description:
This study is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
Heart Failure
Status:
Active, in follow-up
Summary:
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Description:
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Vutrisiran in patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy).
Status:
Enrolling
Summary:
Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68
Description:
This is a multicenter, randomized, double‐blind, parallel group, placebo‐controlled trial to evaluate the effect of in‐hospital initiation of Dapagliflozin on clinical outcomes in patients with Heart Failure with reduced Ejection Fraction who have been stabilized during hospitalization for acute Heart Failure.
Status:
Enrolling
Summary:
Study to Evaluate Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific’s Investigational ICM System
Description:
The primary objective of this study is to collect physiological measurement data and heart failure event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.
Status:
Active, in follow-up
Summary:
Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events
Description:
The overarching goal of this prospective, multicenter study is to utilize data from the Bodyport scale to develop an index that allows for the early detection of worsening heart failure (HF). The Bodyport scale is capable of measuring key HF parameters of congestion and cardiac perfusion on a regular basis in a patient’s home. These data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening HF.
Status
Active, in follow-up
Summary
Reducing Lung CongestIon Symptoms in Advanced Heart Failure (RELIEVE-HF)
Description
This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. The study device, the V-Wave Interartrial Shunt System, includes a permanent implant – the Shunt. The Shunt is placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. By transferring blood from the left to the right atrium, the Shunt is intended to reduce excessive left-sided cardiac filling pressures in patients with advanced Heart Failure.
Interventional Cardiology
Status:
Active, in follow-up
Summary:
Study to Investigate the Efficacy & Safety of CSL112 in Subjects With Acute Coronary Syndrome
Description:
CSL112 is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in acute coronary syndrome (ACS) patients diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation.
Status:
Enrolling
Summary:
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement (COMPLETE TAVR)
Description:
This is a randomized, comparative effectiveness study of staged complete revascularization with Percutaneous Coronary Intervention (PCI) to treat Coronary Artery Disease vs medical management alone in patients with symptomatic aortic valve stenosis undergoing elective transfemoral Transcatheter Aortic Valve Replacement (TAVR).
Status:
Enrolling
Summary:
Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts
Description:
This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).
Status:
Enrollment On Hold, In Follow-up
Summary:
Surveillance Registry for Medtronic Coronary Post-Surveillance
Description:
A registry for the collection of data on coronary percutaneous interventions to help fulfill the new European Medical Devices Regulation requirements.
Status:
Active, in follow-up
Description:
The proposed registry will utilize retrospective and prospective observational methods to assess and compare the characteristics, treatment, and follow-up of confirmed or suspected COVID-19 adult (age ≥ 18 years old) patients presenting with ST segment elevation.
Status:
Active, in follow-up
Summary:
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (DCB)
Description:
This study is to demonstrate the safety & efficacy of the SurVeil DCB for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
Status:
Enrolling
Description:
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post approval setting.
Status:
Enrolling
Summary:
Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
Description:
This multi-center, prospective, randomized controlled study compares PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system.
Status:
Enrolling
Summary:
Impact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)
Description:
This is a prospective, single-blind clinical investigation randomizing subjects to intravascular ultrasound (IVUS)-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio.
FAQs
With several ongoing cardiology clinical trials, it’s essential that each patient is carefully considered to determine if a clinical trial is the right fit for their unique condition and health needs. Your physician will evaluate several factors, including your diagnosis, severity of condition and other treatment options, before deciding if a clinical trial would be the best course of care. If there is a specific clinical trial you are interested in, make sure to talk with your physician about the potential benefits, risks and next steps.
Whether it’s a medication, procedure, device or another type of therapy, clinical trials help the U.S. Food and Drug Administration (FDA) determine which experimental medical interventions may be approved for future use on a larger scale.
For example, pacemakers weren’t available to all patients until they were tested through clinical trials. Now, they’re one of the most proven and trusted treatments for an abnormal heartbeat.
Clinical trials play a crucial role in advancing the future of care and trials are the primary way researchers make new, progressive treatments available to patients to advance the field of medicine and improve patient outcomes.
FDA-regulated and highly rigorous protocols and processes in place to ensure clinical trials are as safe as possible for patients. Different Phases of clinical trials exist to evaluate the effectiveness of a new device, medication or therapy. At Georgia Heart Institute, we only offer clinical trials that are in Phase II – Phase IV; therefore, the device/medication has already successfully completed safety evaluations in Phase I trials.
Donna Patrick, RN, BSN, CCRC is the Cardiology Research Nurse Manager at Northeast Georgia Medical Center where she has over 15 years’ experience in conducting clinical research. She currently leads a team of clinical research staff, who together, are dedicated to maintaining operational effectiveness, quality and compliance. She has a total of over 37 years of nursing experience that includes Emergency/ Trauma, Occupational Health Management and Legal Nurse Consulting. She maintains certification in Clinical Research Coordination and is a member of the Association of Clinical Research Professionals.
Connect With Our Program
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Contact our research team for more information at 770-219-9010. |
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