Clinical Trials

Cardiac Surgery Clinical Trials

Cardiac Surgery Research

UCLA Cardiac Surgery currently is running several national research trials. Our faculty is also active in several clinical and to help innovate and improve upon the current cardiovascular care. Below are listed our current trials that are actively enrolling patients. Other trials can be located on the clinicaltrials.gov website.

Please contact 310-206-8232 for clinical trials.

Active and Enrolling

• ATRICURE: ICE-AFIB IDE Study AtriCure CryoICE Lesions for Persistent and Longstanding Persistent Atrial Fibrillation Treatment during Concomitant On-Pump Endo/Epicardial Cardiac Surgery SPONSOR: Atricure, Inc. Enrolling
• Donor Stellate ganglion harvesting for Electrophysiology study Adequacy of Cardiac Sympathetic Denervation and Mechanisms of Neural Remodeling in Humans Protocol ID: Date: May 8, 2014-
• Lung Transplantation at Night
  Sponsor: N/A Status: Open/Enrolling
• OCS: The Organ Care System (OCS) Lung Thoracic organ perfusion (TOP) registry for donor lungs for transplantation
  Sponsor: TransMedics Status: Open/Enrolling
• OCS: International Trial to Evaluate the Safety and Effectiveness of Portable Organ Care System (OCS) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation (Expand II) Sponsor: TransMedics Status: Open/Enrolling
• RESTORE: A prospective, multi-center trial to evaluate the safety and effectiveness of beating heart mitral valve repair with the HARPOON™ System (RESTORE) SPONSOR: Edwards Enrolling
• RECEPI: following cardiac surgery kidney events (make) in subjects at high risk for Acute Kidney Injury (AKI) SPONSOR: Cerus Enrolling
• TOP Registry for “lung in the box” preservation using Transmedics device: OCS™ Lung TOP Registry for Donor Lungs for Transplantation (TOP)
  Start date August 2018 Currently recruiting
• (TA) Tricuspid Atresia Congenital Heart Surgeons Society (CHSS)
  Study: Enrolling
• (AAOCA) Determining the Natural and "Unnatural" History of Anomalous Aortic Origin of Coronary Artery with Interarterial or Intraconal or Intramural course: Establishing a Multi-Institutional Registry. Congenital Heart Surgeons Society (CHSS): Enrolling
• (LVOTO) Optimal Management of Critical Left Ventricular Outflow Tract Obstruction: A Congenital Heart Surgeons Society Study: Enrolling

Archive Studies

• Alternative Organ Preservation study currently recruiting cases. Donor heart preservation using alternative solution
• ABLATE STUDY: ABLATE AF Registry Trial (AtriCure Synergy Bipolar RF Energy Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment during Concomitant On-Pump Endo/Epicardial Cardiac surgery)
  SPONSOR: Atricure, Inc. DATE: Closed 12/1/2020
• ATS Study: ATS 3fR Aortic Bioprosthesis Model 1000-Post Approval Study
  SPONSOR: ATS Medical, Inc. DATE: Closed 12/1/2010
• BiPACS: Bivcntricular Pacing After Cardiopulmonary Bypass
  SPONSOR: Columbia University DATE: Closed 3/10/2016
• EXPAND Heart Trial: International EXPAND Heart Pivotal Trial (EXPAND Heart) Start date December 2014End date December 2020
• EXPAND Lung Trial: International EXPAND Lung Pivotal Trial (EXPAND Lung) DATES: 2013-2018
• HEMOBLAST vs. Floseal: Prospective, randomized, controlled, multicenter, post-market clinical study evaluating the performance of Hemoblast bellows compared to Floseal hemostatic matrix in cardiothoracic operations
  SPONSOR: Biom’UP DATE: Closed 10/11/2019
• INSPIRE study: International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation (INSPIRE)
  Start date June 2012 End date September 2018 Recruitment completed.
• Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment
  (Mitroflow DL PAS)
  Sponsor: Sorin Status: Closed (2020)
• OCS: Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation
  Sponsor: TransMedics Status: Closed/2016
• OCS: International Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS) Heart for Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND I Heart Trial)
  Sponsor: TransMedics Status: Closed/2019
• OCS: Prospective, Multi-Center Randomized, Clinical Investigation of Transmedics Organ Care System (OCS) for Cardiac Use. (Proceed II)
  Sponsor: TransMedics Status: Closed/2014
• OCS: Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation (Inspire) Sponsor: TransMedics Status: Closed/2016
• PREVENT: PREVENtion of HeartMate II Pump Thrombosis through Clinical Management (PREVENT Study) SPONSOR: Thoratec Corporation DATE: Closed 10/4/2016
• PREVENT II: PREVENtion of Non-Surgical bleeding by Management of HeartMate II Patients without antiplatelet therapy
  SPONSOR: Thoratec Corporation DATE: Closed 6/21/2018
• QUARK: A randomized, double-blind placebo controlled phase 3 study to evaluate the efficacy and safety of QPI-1002 for the prevention of major adverse
  DATE: Closed 03/23/2020
• SynCardia: Temporary Total artificial heart (TAH-T) post market surveillance study (PMSS) SPONSOR: SynCardia Date: Closed 11/6/2014
• SynCardia: Freedom Driver System Study
  SPONSOR: SynCardia Date: Closed 2/5/2015
• SynCardia 50cc: SYNCARDIA 50cc TEMPORARY TOTAL ARTIFICIAL HEART (TAHT) AS A BRIDGE TO TRANSPLANT (BTT)
  SPONSOR: SynCardia DATE: Closed 5/18/2020
• TRANSFORM: Multi-Center Experience with the Rapid Deployment EDWARDS INTUITY Valve System for Aortic Valve Replacement
  SPONSOR: Edwards Closed June 2021
• PARTNER 3 – AVIV: A Prospective, SingleArm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients with a Failing Aortic Bioprosthetic Valve
  SPONSOR: Edwards. DATE: Follow up
• PARTNER 3: A Prospective, Randomized, Controlled, Multi-Center Study to establish the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have severe, calcific, aortic stenosis requiring aortic valve replacement SPONSOR: Edwards. DATE: Follow up