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Research & Clinical Trials

Active Research Studies

The Dr. Kiran C. Patel Research Institute oversees dozens of research studies every year across many clinical disciplines. Patients that are admitted to our hospitals who meet specific criteria for studies may be asked to participate in a research study, but are never obligated to.

If you are interested in participating in one of our trials, you will need to complete a Release of Information form.

Following is a list of research studies that are currently active at our hospital. 


Evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

YouTube Video: ROX Whiteboard HBP Animation

ClinicalTrials.gov Identifier: NCT02895386

Lead: Juliet Bala- juliet.bala@ahss.org


APPRAISE ATP: Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP

The objective is to understand the role of anti-tachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.

ClinicalTrials.gov Identifier: NCT02923726

Lead: Poliana Ayala - poliana.ayala@ahss.org


CONNECT-HF: Care Optimization through Patient and Hospital Engagement Clinical Trial for Heart Failure

Connect-HF is a hospital based quality improvement trial comparing two QI initiatives to standard care on heart failure outcomes (readmissions or all-cause mortality) and HF quality of care metrics at 1 year after discharge for participants hospitalized with acute HF and reduced ejection fraction.

ClinicalTrials.gov Identifier: NCT03035474

Lead: Marissa Hardy – marissa.hardy@ahss.org


CONTROL HTN-02:  A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects with Hypertension

Evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

ClinicalTrials.gov Identifier: NCT02895386

Lead: Juliet Bala – juliet.bala@ahss.org


DREAM HF-1: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.

The primary objective of this study is to determine whether trans-endocardial delivery of allogeneic human bone marrow-derived MPCs (CEP-41750) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.  A Double-blind, Randomized, Sham-procedure-controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (CEP-41750) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology. 

ClinicalTrials.gov Identifier: NCT02032004                    

Lead: Betsy Szymanski –elizabeth.szymanski@ahss.org


GALACTIC-HF:  Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction AMGEN CHF

The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF.

ClinicalTrials.gov Identifier: NCT02929329

Lead:  Betsy Szymanski –elizabeth.szymanski@ahss.org


IDORSIA:  A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease

A multi-center, double-blind, randomized, placebo-controlled study to assess the pharmacodynamics, pharmacokinetics, tolerability, and safety of a single subcutaneous injection of ACT-246475 in adults with stable coronary artery disease.

ClinicalTrials.gov Identifier: NCT03384966

Lead: Marissa Hardy – marissa.hardy@ahss.org


KALIGIA:  A Clinical Study to Collect Calibration and Performance Data of the KBS System 1.0 Non-Invasive Glucose Monitoring Device (KBS002)

The purpose of this study is to calibrate the performance of the KBS-1 non-invasive glucose monitoring device with diabetic people when compared to that of the standard method currently used in the clinical setting for prescription point-of-care (POC) blood glucose monitoring. The secondary purpose of this study is to calibrate the performance of the RBA-1 minimally invasive bodily fluid analyte analyzer device when compared to the results from a prescription POC blood glucose monitoring device and/or standard hospital laboratory blood test.

ClinicalTrials.gov Identifier: NCT03607435

Lead: Juliet Bala – juliet.bala@ahss.org


PIONEER III: A prospective Multicenter Global Randomized controlled Trial Assessing the Safety and Efficacy of the BuMA Supreme Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients with Stable CAD or Non-STEMI ACS Syndromes

The patient population will consist of adults presenting to the hospital with symptomatic ischemic heart disease, including chronic stable angina with evidence of ischemia or acute coronary syndrome (UA or NSTEMI), requiring PCI with drug-eluting stents. Subjects will be randomized 2:1 to revascularization with either the BUMA stent vs. everolimus-eluting stent (Xience, Promus). Subjects will be followed for 5 years.

ClinicalTrials.gov Identifier: 03168776

Lead: Cynthia Paysor – cynthia.paysor@ahss.org


PLEXA:  Master Study of the Ilivia ICD Family and the Plexa ICD Lead

This is a post-market registry study designed to confirm the long-term safety and reliability of the Plexa lead used with a BIOTRONIK ICD or CRT-D device.

ClinicalTrials.gov Identifier: NCT02774616

Lead: Cynthia Paysor – cynthia.paysor@ahss.org


QP EXCELS: Sentus QP-Extended CRT Evaluation With Quadripolar Left Ventricular Leads:

The QP ExCELs study is designed to confirm safety & efficacy of the BIOTRONIK left ventricular leads Sentus OTW QP L & Sentus OTW QP S to satisfy FDA requirements for regulatory approval of the leads in the US.  Long-term safety of the Sentus OTW QP L and Sentus OTW QP S lead will be confirmed during a post approval phase (US sites only).  

ClinicalTrials.gov Identifier: NCT02290028                    

Lead: Cynthia Paysor – cynthia.paysor@ahss.org