Coronary Trials

  • Victorion 2 Prevent

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

If you would like additional information regarding this trial please visit the website below or contact [email protected]

  • Prolocor

This is a Prospective, Observational Multicenter Non-Interventional Cohort Study. The primary objective is to determine whether platelet expression of FcγRIIa is associated with risk of myocardial infarction (MI), stroke and death. Secondary objectives include: 1) Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death; and 2) Determine whether platelet expression of FcγRIIa is associated with risk of major bleeding. The primary endpoint is the composite of death, MI and stroke. A secondary endpoint is the incidence of clinically significant bleeding according to the Bleeding Academic Research Consortium (BARC) scale type 2-5. Approximately 800 male and female subjects with confirmed MI [ST-segment elevation MI (STEMI) or non-ST-segment elevation MI (NSTEMI)] will be enrolled before hospital discharge for the index event. Approximately 10 sites in the United States will participate in this study. It is anticipated that it will take approximately 12 months to enroll approximately 800 subjects. The study and subject follow-up will continue until 1) at least 80 ischemic events (MI, stroke, and death) have occurred, and 2) the last subject enrolled has completed 18 months of follow-up.

If you would like additional information regarding this trial please visit the website below or contact [email protected]

    • Janssen ACS

    The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).

    If you would like additional information regarding this trial please visit the website below or contact [email protected]

    Peripheral Trials

    • CREST II

    Carotid revascularization and medical management for asymptomatic carotid stenosis trial

    If you would like additional information regarding this trial please visit the website below or contact [email protected]

    https://clinicaltrials.gov/ct2/show/NCT02089217

    • Elegance

        The ELEGANCE Registry’s objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

        If you would like additional information regarding this trial please visit the website below or contact [email protected]

        https://clinicaltrials.gov/ct2/show/NCT04674969?term=04674969&draw=2&rank=1

        •  C Guardians

            The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS).

            If you would like additional information regarding this trial please visit the website below or contact [email protected]

            • Radiance

                RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

                If you would like additional information regarding this trial please visit the website below or contact [email protected]

                • Reduced 1

                    The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:  Severe Resistance HTN, Moderate Resistance HTN, and Failed RF Therapy.

                    If you would like additional information regarding this trial please visit the website below or contact [email protected]

                    Structural Heart Trials

                      • AMPLATZER™ PFO Occluder Post-Approval Study

                      AMPLATZER™ PFO Occluder Post Approval Clinical Study is a single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder, in a post approval setting, in patients with a PFO who have had a cryptogenic stroke confirmed by a study neurologist.

                      If you would like additional information regarding this trial please visit the website below or contact [email protected]

                      https://clinicaltrials.gov/ct2/show/NCT03309332

                      •  ACURATE IDE

                      A prospective, multicenter trial designed to evaluate the safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for TAVR in subjects who have sever native aortic stenosis and are indicated for TAVR.

                      If you would like additional information regarding this trial please visit the website below or contact [email protected]

                      Website pending…

                      • SUMMIT

                      Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe, mitral regurgitation.

                      If you would like additional information regarding this trial please visit the website below or contact [email protected]

                      Website pending…

                      •  Empower

                      The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating heart failure with at least mild functional regurgitation.

                        If you would like additional information regarding this trial please visit the website below or contact [email protected]

                        • Repair MR

                        The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

                          If you would like additional information regarding this trial please visit the website below or contact [email protected]

                          EP Trials

                            •   INTERRUPT AF

                            A prospective, non-randomized, multicenter (global), post approval clinical study (PAS) to evaluate open irrigated ablation catheters with high resolution mapping to treat paroxysmal atrial fibrillation.

                            If you would like additional information regarding this trial please visit the website below or contact [email protected]

                            https://clinicaltrials.gov/ct2/show/NCT03729830

                            •  Real AF

                            The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.

                            If you would like additional information regarding this trial please visit the website below or contact [email protected]

                                •  Advantage AF

                                The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).

                                    If you would like additional information regarding this trial please visit the website below or contact [email protected]

                                    • Janssen AF

                                    A study to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.

                                        If you would like additional information regarding this trial please visit the website below or contact [email protected]

                                        • Fire HFpEF

                                        Study  to determine if personalized rate pacing and tachycardia remodeling pacing can favorably remodel HFpEF patients by increasing chamber volume.

                                            If you would like additional information regarding this trial please visit the website below or contact [email protected]

                                            Heart Failure Trials

                                            • Allay HF

                                            Study to evaluate the safety and efficacy of the Alleviant System for no-implant interatrial shunt creation in patients with chronic heart failure.

                                            If you would like additional information regarding this trial please visit the website below or contact [email protected]

                                            https://clinicaltrials.gov/ct2/show/NCT04592445?cond=rebalance+hf&draw=2&rank=1

                                                Registry 

                                                  • Care HF

                                                  Cardiovascular and renal treatment in heart failure patients with Hyperkalemia or at high risk of hyperkalemia

                                                  If you would like additional information regarding this trial please visit the website below or contact [email protected]

                                                  More Coming soon…..