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Boston Scientific Corporation
Traitements, essais et publications liés.
Traitements23programmes
Essais15liés
Publications5liées
SourceDBlocale
Traitements
23| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| Ablation Treatment with FARAPULSE™ Pulsed Field Ablation (PFA) System and OPAL HDx™ Mapping SystemThe objective of this study is to obtain experience with new and modified components of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used with the OPAL HDx™ Mapping System for the treatment of Atrial Fibrillation (AF). | Maladie coronarienne | Non applicable | À vérifier | Croatia, Czechia, France | À vérifier |
| FARAPULSE Pulsed Field Ablation SystemThe study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters. | Maladie coronarienne | À vérifier | À vérifier | Austria, France, Germany, Greece, Ireland, Italy, Monaco, Netherlands, … | À vérifier |
| FARAPULSE™ PFA system and WATCHMAN LAAC Delivery SystemsSubjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure. | Maladie coronarienne | À vérifier | À vérifier | China, Hong Kong, Japan, Malaysia, Singapore, Taiwan | À vérifier |
| FARAPULSE™ Pulsed Field Ablation SystemThe ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters. | Maladie coronarienne | À vérifier | À vérifier | United States, Brazil, Canada, Chile | À vérifier |
| Implant of investigational device systemThe NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms. | Insuffisance cardiaque | Non applicable | À vérifier | Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom | À vérifier |
| Non-Vitamin K Oral AnticoagulantThe primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation. | Accident vasculaire cérébral | Non applicable | À vérifier | United States, Australia, Belgium, Canada, Denmark, France, Germany, Israel, … | À vérifier |
| Pleneva TM BGC20-0134To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134. | SEP | Phase 2 | À vérifier | Belgium, France, Germany, Poland, Russia, Spain | À vérifier |
| PrecisionThe purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed. | Migraine | Non applicable | À vérifier | United States | À vérifier |
| Titration after the randomization phaseThe NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms. | Insuffisance cardiaque | Non applicable | À vérifier | Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom | À vérifier |
| Titration during the randomization phaseThe NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms. | Insuffisance cardiaque | Non applicable | À vérifier | Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom | À vérifier |
| WATCHMAN Elite LAAC DeviceThe primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke. | Accident vasculaire cérébral, Maladie coronarienne | Non applicable | À vérifier | United States | À vérifier |
| WATCHMAN FLX LAAC DeviceThe primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation. | Accident vasculaire cérébral | Non applicable | À vérifier | United States, Australia, Belgium, Canada, Denmark, France, Germany, Israel, … | À vérifier |
| PrecisionThe purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed. | Migraine | Phase 2 | À vérifier | United Kingdom | À vérifier |
| PrecisionThe purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed. | Migraine | Non applicable | À vérifier | United States | À vérifier |
| WATCHMAN Elite LAAC DeviceThe primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke. | Accident vasculaire cérébral | Non applicable | À vérifier | United States | À vérifier |
| WATCHMAN FLX LAAC DeviceThe primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation. | Accident vasculaire cérébral | Non applicable | À vérifier | United States, Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom | À vérifier |
| FARAPULSE Pulsed Field Ablation SystemThe study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters. | Maladie coronarienne | À vérifier | À vérifier | Austria, France, Germany, Greece, Ireland, Italy, Monaco, Netherlands, Spain, Switzerland | À vérifier |
| FARAPULSE™ Pulsed Field Ablation SystemThe ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters. | Maladie coronarienne | Non applicable | À vérifier | United States, Australia, Taiwan | À vérifier |
| FARAPULSE™ Pulsed Field Ablation SystemThe ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters. | Maladie coronarienne | À vérifier | À vérifier | United States, Brazil, Canada, Chile | À vérifier |
| FARAPULSE™ PFA system and WATCHMAN LAAC Delivery SystemsSubjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure. | Maladie coronarienne | À vérifier | À vérifier | China, Hong Kong, Japan, Malaysia, Singapore, Taiwan | À vérifier |
| Implant of investigational device systemThe NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms. | Insuffisance cardiaque | Non applicable | À vérifier | Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom | À vérifier |
| Pleneva TM BGC20-0134To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134. | SEP | Phase 2 | À vérifier | Belgium, France, Germany, Poland, Russia, Spain | À vérifier |
| Ablation Treatment with FARAPULSE™ Pulsed Field Ablation (PFA) System and OPAL HDx™ Mapping SystemThe objective of this study is to obtain experience with new and modified components of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used with the OPAL HDx™ Mapping System for the treatment of Atrial Fibrillation (AF). | Maladie coronarienne | Non applicable | À vérifier | Croatia, Czechia, France | À vérifier |
Essais cliniques
15| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Ablation Treatment with FARAPULSE™ Pulsed Field Ablation (PFA) System and OPAL HDx™ Mapping System | Maladie coronarienne | Non applicable | NCT07925359 | NAVigate-ULTRA — The Evaluation of User Experience With FARAVIEW™ Technology of the OPAL HDx™ Mapping System When Used With the FARAWAVE NAV™ ULTRA Pulsed Field Ablation Catheter in the Treatment of Atrial Fibrillation | NOT_YET_RECRUITING |
| Pleneva TM BGC20-0134 | SEP | Phase 2 | NCT01037907 | A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | TERMINATED |
| Implant of investigational device system | Insuffisance cardiaque | Non applicable | NCT01385176 | Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) | ACTIVE_NOT_RECRUITING |
| FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems | Maladie coronarienne | À vérifier | NCT06686485 | OPTION-A — Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia | ACTIVE_NOT_RECRUITING |
| FARAPULSE™ Pulsed Field Ablation System | Maladie coronarienne | À vérifier | NCT06431815 | ADVENTPAS — ADVENT Post Approval Study | ACTIVE_NOT_RECRUITING |
| FARAPULSE™ Pulsed Field Ablation System | Maladie coronarienne | Non applicable | NCT06735534 | ReMATCH — Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System | ACTIVE_NOT_RECRUITING |
| FARAPULSE Pulsed Field Ablation System | Maladie coronarienne | À vérifier | NCT06808217 | OPALISE — A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation | ACTIVE_NOT_RECRUITING |
| WATCHMAN FLX LAAC Device | Accident vasculaire cérébral | Non applicable | NCT04394546 | CHAMPION-AF Clinical Trial | ACTIVE_NOT_RECRUITING |
| WATCHMAN Elite LAAC Device | Accident vasculaire cérébral | Non applicable | NCT07287436 | Elite AF IDE Trial (Elite AF) | RECRUITING |
| Deep Brain Stimulation | Parkinson | À vérifier | NCT03664609 | Deep Brain Stimulation (DBS) Retrospective Outcomes Study | RECRUITING |
| Radiofrequency Ablation | Parkinson | À vérifier | NCT06553625 | Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS | RECRUITING |
| Precision | Migraine | Non applicable | NCT00286078 | Treatment for Migraines With an Implantable Device | COMPLETED |
| Precision | Migraine | Phase 2 | NCT00747812 | PRISM UK — Study of Occipital Nerve Stimulation for Drug Refractory Migraine | TERMINATED |
| Deep Brain Stimulation | Épilepsie | Non applicable | NCT07458217 | CoSMos — Combined CM and STN Stimulation for Motor Epilepsy | RECRUITING |
| Deep Brain Stimulation (DBS) | Parkinson | À vérifier | NCT02071134 | Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry | RECRUITING |
Publications
5| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Implant of investigational device system | Current aspects in surgical treatment of advanced heart failure with future durable mechanical circulatory support. | European surgical research. Europaische chirurgische Forschung. Recherches chirurgicales europeennes | ||
| Implant of investigational device system | Contemporary Management of Knee Chondral Defects, Part III: Cell-Based Cartilage Repair Including Autologous Chondrocyte Implantation, Orthobiologics, and Tissue-Engineered Constructs. | The journal of knee surgery | ||
| Implant of investigational device system | Balloon-Expandable Covered Stents as Iliac Limbs During Complex EVAR. | Annals of vascular surgery | ||
| Precision | The perspective of artificial intelligence for NMR. | Magnetic resonance letters | ||
| Precision | Going high-throughput: Dynamic conformations and interactions . | Magnetic resonance letters |