FIAB SpA — Biomedical Watch V2

Traitements3programmes

Essais1liés

Publications6liées

SourceDBlocale

Traitements

3

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Lead insertionThe objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: * safety in terms of freedom from Serious Adverse Events(SADEs); * performance in terms of Mean Pacing Capture Threshold. Secondary objectives are to assess: * safety in terms of freedom from Adverse Events (ADEs); * performance in terms of Mean Pacing Impedance; * performance in terms of Sensed R-wave Amplitude. The study is a prospective, non-randomized, single-arm, multi-center investigation in 131 adult subjects with 3 investigational sites in Italy. The study is expected to take approximately 1 year to enroll. Enrolled subjects will have visit timepoints at: baseline, lead insertion, lead removal, discharge and 30 days post lead removal.	Maladie coronarienne	Non applicable	À vérifier	Italy	À vérifier
lead removalThe objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: * safety in terms of freedom from Serious Adverse Events(SADEs); * performance in terms of Mean Pacing Capture Threshold. Secondary objectives are to assess: * safety in terms of freedom from Adverse Events (ADEs); * performance in terms of Mean Pacing Impedance; * performance in terms of Sensed R-wave Amplitude. The study is a prospective, non-randomized, single-arm, multi-center investigation in 131 adult subjects with 3 investigational sites in Italy. The study is expected to take approximately 1 year to enroll. Enrolled subjects will have visit timepoints at: baseline, lead insertion, lead removal, discharge and 30 days post lead removal.	Maladie coronarienne	Non applicable	À vérifier	Italy	À vérifier
Lead insertionThe objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: * safety in terms of freedom from Serious Adverse Events(SADEs); * performance in terms of Mean Pacing Capture Threshold. Secondary objectives are to assess: * safety in terms of freedom from Adverse Events (ADEs); * performance in terms of Mean Pacing Impedance; * performance in terms of Sensed R-wave Amplitude. The study is a prospective, non-randomized, single-arm, multi-center investigation in 131 adult subjects with 3 investigational sites in Italy. The study is expected to take approximately 1 year to enroll. Enrolled subjects will have visit timepoints at: baseline, lead insertion, lead removal, discharge and 30 days post lead removal.	Maladie coronarienne	Non applicable	À vérifier	Italy	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
Lead insertion	Maladie coronarienne	Non applicable	NCT07820072	SPIKE FLOW Endocardial Lead Safety and Performance Study	RECRUITING

Publications

6

Molécule	Indication / population	Titre	Journal	Date
Lead insertion		Comparative analysis of ultrasound-guided versus fluoroscopy-guided venous puncture techniques for pacemaker implantation.	Heart and vessels
Lead insertion		'Asleep' deep brain stimulation targeting ventral intermediate thalamus in essential tremor: systematic review.	British journal of neurosurgery
Lead insertion		The flexibility of delayed fluoroscopic left ventricular angiography in periprocedural real-time visualization of the lead tip in left bundle branch pacing.	Heart rhythm O2
lead removal		Safety and Outcomes of Transvenous Lead Extraction of Advisory ePTFE-Coated Implantable Cardioverter-Defibrillator Leads: A Multicenter Experience With RELIANCE G.	JACC. Clinical electrophysiology
lead removal		Confluence of nanotechnology and phytoremediation for lead detoxification using .	International journal of phytoremediation
lead removal		Retraction notice to "Artificial neural networks modeling for lead removal from aqueous solutions using iron oxide nanocomposites from bio-waste mass" [Environ. Res. 199 (2021) 111370].	Environmental research