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Abbott Medical Devices
Traitements, essais et publications liés.
Traitements22programmes
Essais8liés
Publications4liées
SourceDBlocale
Traitements
22| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| Ablation procedure with DuoVT PFA systemThis study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System. | Maladie coronarienne | Non applicable | À vérifier | Croatia, Czechia, Italy, Spain | À vérifier |
| AMJ-401A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan | Maladie coronarienne | Non applicable | À vérifier | Japan | À vérifier |
| Coronary and peripheral stentsThe AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate. | Maladie coronarienne | À vérifier | À vérifier | United States, Australia, Austria, Belgium, China, France, Germany, Hungary, … | À vérifier |
| Coronary dilatation cathetersThe AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate. | Maladie coronarienne | À vérifier | À vérifier | United States, Australia, Austria, Belgium, China, France, Germany, Hungary, … | À vérifier |
| Left Atrial Appendage Occluder ImplantThe objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO. | Maladie coronarienne | Non applicable | À vérifier | Belgium, Czechia, Denmark, Germany, Ireland, Italy, Lithuania, Poland, … | À vérifier |
| Left Bundle Branch ImplantThis clinical investigation is a prospective, single-arm, multi-center, observational study designed to evaluate the concordance between a simplified electrocardiogram (ECG) method implemented on the Merlin™ 3650 or MER3700 programmer and the standard 12-lead ECG during left bundle branch area pacing (LBBAP) in patients with a bradycardia indication for pacemaker implantation. The study will enroll approximately 50 subjects across up to 5 U.S. sites, with data collected during the implant procedure, and optionally post-implant at the pre-discharge evaluation. No post-discharge follow-up is planned. | Insuffisance cardiaque | À vérifier | À vérifier | À vérifier | |
| Measurement and imaging (FFR and OCT)The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate. | Maladie coronarienne | À vérifier | À vérifier | United States, Australia, Austria, Belgium, China, France, Germany, Hungary, … | À vérifier |
| Pacing cathetersThe AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate. | Maladie coronarienne | À vérifier | À vérifier | United States, Australia, Austria, Belgium, China, France, Germany, Hungary, … | À vérifier |
| Peripheral dilatation cathetersThe AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate. | Maladie coronarienne | À vérifier | À vérifier | United States, Australia, Austria, Belgium, China, France, Germany, Hungary, … | À vérifier |
| Pulsed Field AblationThis clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation. | Maladie coronarienne | Non applicable | Traitement symptomatique | Australia, Austria, Belgium, Czechia, Germany, Netherlands, Spain | À vérifier |
| PVI AblationThe objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO. | Maladie coronarienne | Non applicable | À vérifier | Belgium, Czechia, Denmark, Germany, Ireland, Italy, Lithuania, Poland, … | À vérifier |
| Relief — Peripheral Nerve Stimulation Registry for Intractable Migraine HeadacheThe purpose of this study is to evaluate the long-term safety and performance of neurostimulation for the treatment of intractable chronic migraine as well as to detect infrequent complications or problems only apparent in "real-world" practice | Migraine | À vérifier | À vérifier | Belgium, Germany, Luxembourg, Spain, Sweden, United Kingdom | À vérifier |
| Tricuspid Transcatheter Edge-to-Edge Repair (TEER)The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use. | Maladie coronarienne | À vérifier | À vérifier | United States, France, Germany, Italy, Spain | À vérifier |
| Vascular plugsThe AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate. | Maladie coronarienne | À vérifier | À vérifier | United States, Australia, Austria, Belgium, China, France, Germany, Hungary, … | À vérifier |
| Relief — Peripheral Nerve Stimulation Registry for Intractable Migraine HeadacheThe purpose of this study is to evaluate the long-term safety and performance of neurostimulation for the treatment of intractable chronic migraine as well as to detect infrequent complications or problems only apparent in "real-world" practice | Migraine | À vérifier | À vérifier | Belgium, Germany, Luxembourg, Spain, Sweden, United Kingdom | À vérifier |
| AMJ-401A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan | Maladie coronarienne | Non applicable | À vérifier | Japan | À vérifier |
| Ablation procedure with DuoVT PFA systemThis study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System. | Maladie coronarienne | Non applicable | À vérifier | Croatia, Czechia, Italy, Spain | À vérifier |
| Coronary and peripheral stentsThe AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate. | Maladie coronarienne | À vérifier | À vérifier | United States, Australia, Austria, Belgium, China, France, Germany, Hungary, Italy, Netherlands, Spain, Switzerland, Taiwan, United Arab Emirates | À vérifier |
| Left Bundle Branch ImplantThis clinical investigation is a prospective, single-arm, multi-center, observational study designed to evaluate the concordance between a simplified electrocardiogram (ECG) method implemented on the Merlin™ 3650 or MER3700 programmer and the standard 12-lead ECG during left bundle branch area pacing (LBBAP) in patients with a bradycardia indication for pacemaker implantation. The study will enroll approximately 50 subjects across up to 5 U.S. sites, with data collected during the implant procedure, and optionally post-implant at the pre-discharge evaluation. No post-discharge follow-up is planned. | Insuffisance cardiaque | À vérifier | À vérifier | À vérifier | |
| PVI AblationThe objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO. | Maladie coronarienne | Non applicable | À vérifier | Belgium, Czechia, Denmark, Germany, Ireland, Italy, Lithuania, Poland, Spain, United Kingdom | À vérifier |
| Pulsed Field AblationThis clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation. | Maladie coronarienne | Non applicable | Traitement symptomatique | Australia, Austria, Belgium, Czechia, Germany, Netherlands, Spain | À vérifier |
| Tricuspid Transcatheter Edge-to-Edge Repair (TEER)The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use. | Maladie coronarienne | À vérifier | À vérifier | United States, France, Germany, Italy, Spain | À vérifier |
Essais cliniques
8| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Tricuspid Transcatheter Edge-to-Edge Repair (TEER) | Maladie coronarienne | À vérifier | NCT07586995 | TREAT TR — A Post-Market Assessment of the Safety and Performance of the TriClip™ System | RECRUITING |
| Pulsed Field Ablation | Maladie coronarienne | Non applicable | NCT06106594 | VOLT CE Mark Study | ACTIVE_NOT_RECRUITING |
| PVI Ablation | Maladie coronarienne | Non applicable | NCT07523620 | CLEAR — Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration | RECRUITING |
| Left Bundle Branch Implant | Insuffisance cardiaque | À vérifier | NCT07877805 | Merlin Expanded ECG NSR | NOT_YET_RECRUITING |
| Coronary and peripheral stents | Maladie coronarienne | À vérifier | NCT04573660 | AV-MDR — Abbott Vascular Medical Device Registry | RECRUITING |
| Ablation procedure with DuoVT PFA system | Maladie coronarienne | Non applicable | NCT07706712 | EXACT-VT — Evaluation of the DuoVT PFA System for Ventricular Tachycardia | RECRUITING |
| AMJ-401 | Maladie coronarienne | Non applicable | NCT07373353 | A Clinical Evaluation of AMJ-401 | ACTIVE_NOT_RECRUITING |
| Relief — Peripheral Nerve Stimulation Registry for Intractable Migraine Headache | Migraine | À vérifier | NCT02227758 | Relief — Peripheral Nerve Stimulation Registry for Intractable Migraine Headache | COMPLETED |
Publications
4| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Tricuspid Transcatheter Edge-to-Edge Repair (TEER) | Intraprocedural evaluation of residual mitral and tricuspid regurgitation after transcatheter edge-to-edge repair. | International journal of cardiology | ||
| Tricuspid Transcatheter Edge-to-Edge Repair (TEER) | Tricuspid transcatheter edge-to-edge repair versus transcatheter tricuspid valve replacement - what are the key issues? | Current opinion in cardiology | ||
| Tricuspid Transcatheter Edge-to-Edge Repair (TEER) | Changes in right ventricular-pulmonary artery coupling after transcatheter edge-to-edge repair in primary and atrial mitral regurgitation. | International journal of cardiology | ||
| Relief — Peripheral Nerve Stimulation Registry for Intractable Migraine Headache | Peripheral nerve stimulation registry for intractable migraine headache (RELIEF): a real-life perspective on the utility of occipital nerve stimulation for chronic migraine. | Acta neurochirurgica |