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