Now Enrolling: Heart & Vascular Clinical Trials

UVA Health frequently opens new clinical trials, offering your patients the latest investigational treatments. Below is a list of trials now enrolling at UVA Heart & Vascular Center.

Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study (IRB #19773)

To establish the safety and feasibility of the Edwards SAPIEN III valve in subject with mitral annular calcification (MAC) associated with mitral stenosis and/or mitral regurgitation who are high-risk for mitral valve surgery, or deemed inoperable. (NCT02830204)

Inclusion Criteria

  • Severe MAC associated with MS and/or MR
  • High risk or inoperable for surgical MR                   
  • The following concomitant procedures are allowed: MAZE, TVR, AF ablation, CABG and septal myectomy

Exclusion Criteria

  • LVEF <30%
  • End-stage renal disease requiring dialysis
  • Echo evidence of LV mass, thrombus, or concerns of active infective endocarditis

Primary Investigator: Gorav Ailawadi, MD
Clinical Research Coordinator: Christine Bernat, RN

Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA) (IRB #180035) To compare the efficacy of AGN-151607 with placebo to prevent post-op atrial fibrillation in participants undergoing open-chest cardiac surgery. (NCT03779841)

Inclusion Criteria

  • 55 to 90 years of age                                                                        
  • In sinus rhythm for the last 48 hours prior to surgery
  • Willing to wear ECG patch 30 days post-surgery and for 7 days after each study visit

Exclusion Criteria

  • Permanent or persistent AF
  • Severe atrial enlargement (>55mm)
  • LVEF < 25%
  • Pre-op need for inotropes/vasopressors or IABP
  • History of ablation of AF                                                             
  • Presence or history of symptomatic AV block > 1st degree within last 30 days

Primary Investigator: Gorav Ailawadi, MD
Clinical Research Coordinator: Matt Kime

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG (PACES) (IRB #190034)                                    

To evaluate the effectiveness and safety of adding OAC to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. (NCT4045665)

Inclusion Criteria

  • Isolated CABG                                                                      
  • POAF that persist for >60 mins or is recurrent within 7 days after index CABG

Exclusion Criteria

  • History of either permanent, persistent, or paroxysmal AF
  • Contraindication for OAC
  • Planned use of DAPT
  • Stage IV or V CKD (eGFR <30)                                                  
  • Liver cirrhosis or Child-Pugh Class C chronic liver disease      

Primary Investigator: Gorav Ailawadi, MD
Clinical Research Coordinator: Matt Kime

Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis (EARLY TAVR) (IRB #19930)

Evaluation of transcatheter AVR compared to surveillance for patients with asymptomatic severe aortic stenosis. (NCT03042104)

Inclusion Criteria:                                                                                 

  • ≥ 65 yo                                                                           
  • AVA 1 cm2 or less or AVA index 0.6 cm2/m2 or less
  • Jet velocity of 4 m/s or greater OR 2) mean gradient of 40 mmHg
  • Asymptomatic

Exclusion Criteria:

  • GFR < 30
  • Prior valve replacement
  • Severe AR or MR
  • Moderate MR

Primary Investigator: Gorav Ailawadi, MD

Primary Investigator: Gorav Ailawadi, MD
Clinical Research Coordinator: Christine Bernat, RN

QRK309 QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery (IRB #180025)

To assess the efficacy of a single IV infusion of QPI-1002 in preventing Major Adverse Kidney Events in subjects at high risk of AKI following cardiac surgery. (NCT03510897)

Inclusion Criteria

  • Stable pre-op renal function and no known increase in SCr of > 0.3 mg/dL during preceding 28 days                                                          
  • eGFR < 60 OR diabetes with ongoing insulin treatment OR urine albumin/creatinine ratio >30
  • CABG + valve OR redo surgery OR more than one valve OR CABG and/or valvue + aortic root or ascending part of the aorta

Exclusion Criteria

  • eGFR < 30
  • Off pump surgery
  • Active HCV
  • Cardiogenic shock prior to surgery                
  • Chronic liver disease 

Primary Investigator: Nicholas Teman, MD
Clinical Research Coordinator: Christine Bernat, RN

Angion GUARD: Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass (IRB #190033)

Inclusion Criteria

  • At increased risk of AKI                                                                                    
  • BMI < 40 at screening
  • Stable pre-op renal function and no known increase in SCr of > 0.3 between time of screening and pre-surgery

Exclusion Criteria

  • eGFR < 20
  • Current active infection
  • Shock liver
  • Cardiogenic shock within 24hrs prior to randomization

Primary Investigator: Nicholas Teman, MD
Clinical Research Coordinator: Christine Bernat, RN