For more than 50 years, Los Robles Health System has led the way in providing a full range of diagnostic and treatment options for all areas of cardiovascular and neurovascular care, leading to the best outcomes for our patients. Our outcomes for heart and neurovascular care are consistently in the nation’s top 10 percent and we participate in multiple cutting-edge clinical trials.
Our multi-disciplinary cardiovascular team focuses on heart and vascular health, from diagnosis of heart disease to management of heart failure and everything in between.
Our dedicated multidisciplinary team of neurovascular professionals utilize state-of-the-art technology and clinical practices in neuroimaging, endovascular device development and advanced techniques in image guided minimally invasive surgery.
Our first and most important responsibility is to our patients and their families, ensuring they receive the best healthcare possible.
Heart clinical trials
Los Robles Health System conducts research for a wide range of cardiovascular disorders and offers patients opportunities to participate in research and clinical trials. Below is more information about clinical trials currently underway at Los Robles.
Abbott MitraClipTM Expand G4: MitraClipTM G4 System Evaluate the safety and performance of the MitraClipTM G4 System in a post-market setting. (NCT 04177394)
Abbott Portico NG: Evaluation of the Portico™ NG Transcatheter Aortic Valve in High and Extreme Risk Patients with Symptomatic Severe Aortic Stenosis. (NCT 02701283)
Abbott Repair MR: Percutaneous MitraClipTM Device or Surgical Mitral Valve Repair in Patients with Primary Mitral Regurgitation who are Candidates for Surgery (REPAIR-MR). (NCT 04198870)
Abbott SUMMIT: Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne
Mitral Valve Replacement System for the Treatment of Symptomatic Mitral Regurgitation. (NCT 03133274)
Abbott TRILUMINATE Pivotal: Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal. Evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR) who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery. (NCT 03904147)
atHeart Medical ASCENT ASD: Evaluation of the safety and efficacy of the atHeart Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant secundum atrial septal defect. Patients with clinically significant secundum atrial septal defect, defined as presence of right ventricular overload who, in the judgment of the treating physician, require, and are suitable for, transcatheter device closure (ASCENT-ASD STUDY) (NCT 04591392)
Bioventrix ALIVE trial: American Less Invasive Ventricular Enhancement -The Revivent system for the treatment of post infarction (AMI) ischemic heart failure through catheter based ventricular repair. (NCT 02931240)
Boston Scientific Champion AF: WATCHMAN FLX versus NOAC for Embolic Protection in the Management of Patients with Non-Valvular Atrial Fibrillation. (NCT 04394546)
Boston Scientific Millipede MR: A study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation. To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. (NCT 04147884)
Boston Scientific Protected TAVR: Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement. The objective of this study is to demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of periprocedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR). (NCT 02214277)
CLASP IID + IIF: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClipTM in patients with mitral regurgitation. (NCT 03706833)
HighLife Medical HIGHLIFE HL-2019-01: An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System. (NCT 04029337)
Medtronic SMART: SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial. The purpose of this trial is to generate clinical evidence on valve safety and performance of self‐expanding (SE) versus balloon‐expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. (NCT 04722250)
V-WAVE RELIEVE-HF TRIAL: Provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System to reduce lung congestion symptoms and improve clinical outcomes in a certain high-risk subset of symptomatic patients suffering from heart failure. (NCT 03499236)
Contact us to learn more about these and upcoming clinical trials at Los Robles Health System.
Maria Cabral-Aoki – Cardiovascular Research Coordinator
HCA Research Institute at Los Robles Health System
227 West Janss Rd., Suite 340
Thousand Oaks, CA 91360
Phone: (805) 208-3413
Email: Email Maria
Neurovascular clinical trials
In close collaboration with HCA Research Institute, Los Robles Health System is engaged in several cutting-edge trials, with many more in the pipeline:
- The APPLY Study: A Prospective, Single-Center Study Appraising the Embolization of Aneurysms using the Balt Optima™ Coil System
- Sponsor: Vascular Neurology of Southern California, Inc.
- The APPLY Study is an investigator-initiated prospective, real-world, single-center, post-market study conducted in Thousand Oaks, California. The purpose of this study is to demonstrate the efficacy and safety of the Balt Optima™ Coil System in the treatment of intracranial aneurysms. (NCT 04499508)
- ASSIST Registry
- Sponsor: Stryker Neurovascular
- The ASSIST Registry is prospective, global, consecutive enrollment Registry, which aims to determine the success of procedural and clinical outcomes associated with various mechanical thrombectomy techniques using Stryker Neurovascular devices in treatment of large vessel occlusions found in the anterior circulation. (NCT 03845491)
- COMPLETE Registry: International Acute Ischemic Stroke Registry with the Penumbra System Aspiration including the 3D Revascularization Device
- Sponsor: Penumbra, Inc.
- The COMPLETE Registry is a prospective, single-arm, multi-center observational registry that aims to collect real-world data on the performance and safety the 3D Revascularization Device as part of the Penumbra System in treatment of acute ischemic strokes by removing large vessel occlusions. The study includes sites across the globe. (NCT 04106583)
- EXCELLENT Registry: Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy
- Sponsor: Cerenovus
- The EXCELLENT Registry is a prospective, single-arm, real-world, multi-center study with sites located globally which aims to assess the efficacy of the EmboTrap Revascularization Device.
- STEM Trial: The SQUID Trial for the Embolization of the Middle Meningeal Artery (STEM) For Treatment of Chronic Subdural Hematoma
- Sponsor: Balt USA, LLC
- The STEM Trial is a prospective, international, multi-center, randomized study established in effort to provide assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization of Chronic Subdural Hematoma. (NCT 04410146)
- SUCCESS Study: Success in Comaneci-assist Coils Embolization Surveillance Study
- Sponsor: Rapid Medical
- SUCCESS is a multi-center, single arm, prospective, post-market surveillance study aimed to assess safety and performance of the Comaneci Embolization Assist Device as it is indicated for use as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms. (NCT 04518670)
- SURF Study: A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms using WAVE Extra Soft Coils, as part of the Penumbra SMART COIL System
- Sponsor: Penumbra, Inc.
- The SURF Study is a prospective, multi-center, real-world, post-market study with sites across North America that aims to establish the safety and efficacy of the Penumbra SMART COIL System, this includes the WAVE Extra Soft Coils in the treatment of intracranial aneurysms. The system works as a fill and finish coil that is meant to adequately embolize various neurovascular lesions. (NCT 04106583)
- TESLA Trial
- Sponsor: Investigator-Initiated Study funded by Genentech, Cerenovus, Medtronic, Penumbra, Stryker
- The TESLA Trial is a prospective, randomized, open-label, blinded endpoint study that aims to determine the efficacy of intra-arterial mechanical thrombectomy in the treatment of acute ischemic stroke due to a large vessel occlusion in the anterior circulation that are currently not candidates for thrombectomy. (NCT 03805308)
- TIGER Study: Treatment with Intent to Generate Endovascular Reperfusion
- Sponsor: Rapid Medical
- The TIGER Study is a prospective, single-arm, multi-center, IDE study with sites located in the United States and parts of Europe. The study is looking to evaluate the safety and effectiveness of the Tigertriever device. The Tigertriever assists in restoring blood flow to vessels of the brain by removing large vessel occlusions in event of ischemic stroke. (NCT04518670)