Impulse Dynamics — Biomedical Watch V2

Traitements5programmes

Essais2liés

Publications0liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini SystemThe AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.	Insuffisance cardiaque	Non applicable	À vérifier	United States	À vérifier
OPTIMIZER® Integra CCM-D System (Treatment Arm)The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.	Insuffisance cardiaque, Maladie coronarienne	Non applicable	Traitement symptomatique	United States	À vérifier
OPTIMIZER™ Smart Mini SystemThe AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.	Insuffisance cardiaque	Non applicable	À vérifier	United States	À vérifier
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini SystemThe AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.	Insuffisance cardiaque	Non applicable	À vérifier	United States	À vérifier
OPTIMIZER® Integra CCM-D System (Treatment Arm)The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.	Maladie coronarienne	Non applicable	Traitement symptomatique	United States	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
OPTIMIZER® Integra CCM-D System (Treatment Arm)	Maladie coronarienne	Non applicable	NCT05855135	INTEGRA-D — Assessment of Combined CCM and ICD Device in HFrEF	ACTIVE_NOT_RECRUITING
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System	Insuffisance cardiaque	Non applicable	NCT05064709	AIM HIGHer — Assessment of CCM in HF With Higher Ejection Fraction	RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.