Clinical Trials

We partner with medical device manufacturers and pharmaceutical companies to offer our patients the opportunity to participate in promising clinical trials. This research may lead to significant improvement in the care and treatment of patients in Fairfield County and around the world. The clinical research staff of the Cardiology Associates Clinical Research Group brings depth of knowledge and experience to the challenges of conducting ethically sound and valuable clinical research. With a large, active patient population and the resources to manage their needs, CAFC is looking to the future and an expansion of our research efforts. If you have any questions or are interested in learning more about our research capabilities, please click on the Contact Us button below.

CAPABILITIES

  • Experience conducting 50+ clinical trials, including Phase II, Phase IIIa, IIIb, as well as IV, IND (Investigational New Drug/Device), and IDE (Investigational Device Exemption) trials
  • Extensive experience with a variety of local & central IRBs, as well as CMS approval for IDE studies
  • NO FDA audits, sanctions, citations, or early termination of trials
  • High rate of patient follow-up sustained by the cultivation of close & trusting relationships with patients
  • Three full-time fully certified coordinators with a combined 16 years of clinical trial experience
    • Fully trained in Good Clinical Practice, Human Subject Protection, FDA Regulations, IATA Regulations, Phlebotomy, Electronic Data Capture, Electronic Medical Records, and Basic Clinical Skills
  • Three main research offices equipped with:
    • Research office with locked/temperature-controlled storage for patient files and investigational product
    • Designated research exam room with computer, internet, phone, blood pressure cuff, phlebotomy equipment, exam table, centrifuge, temperature monitored refrigerator, temperature monitored non-cycling -20ofreezer, ability to store frozen samples
    • 22 physicians who actively refer patients for research studies
    • 11 physicians with direct clinical research experience as PI or Sub-I
    • 5 Nurse Practitioners/APRNs with research experience
  • Patient database of 120,000 charts & access to three major hospitals in Fairfield County
    • Vincent’s Medical Center (HHC Health), Norwalk Hospital, and Stamford Hospital
  • Successful enrollment and experience in cardiovascular clinical trials including:
    • #1 top national enroller for three large scale CAD Risk/Hyperlipidemia trials
    • #2 top national enroller for atrial fibrillation trial
    • #2 top international enroller for implantable device trial
    • #4 top national enroller for dual antiplatelet trial
    • #4 top international enroller for implantable device trial
    • Top national enroller for cardiac rhythm management registry trial- over 500 participants enrolled
  • Daily prescreening of all patients coming into the practice and daily screening of the hospital for potential research study candidates
  • Physician and research coordinator on call 24 hours a day

Trials

Arrhythmia

Atrial Fibrillation / Atrial Flutter
AZALEA (Anthos/TMI)
Abelacimab vs. Rivaroxaban
Paroxysmal Supraventricular Tachycardia
RAPID (Milestone)
Etripamil vs. Placebo for the rapid termination of PSVT episodes

oronary Artery Disease / Dyslipidemia

VICTORIAN-INITIATE (Novartis)
Inclisiran vs. Standard of Care
VICTORIAN-INCEPTION (Novartis)
Inclisiran vs. Standard of Care for patients with recent acute coronary syndrome
ORION-4 (Novartis)
Inclisiran vs. Placebo
VESALIUS-CV (Amgen)
Repatha vs. Placebo

Device Trials

Mitral Regurgitation & Stenosis

EXPAND G4 (Abbott)

Aortic Valve Regurgitation & Stenosis

Optimize PRO (Medtronic)