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A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the SPIKE FLOW Endocardial Lead
Sponsor: FIAB SpA
Summary
The 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 ADEs; * performance in terms of Mean Pacing Capture Threshold. Secondary objectives are to assess: * safety in terms of freedom from 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 Up to 4 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 30d post lead removal.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
131
Start Date
2026-08-07
Completion Date
2027-08
Last Updated
2026-09-15
Healthy Volunteers
No
Interventions
Lead insertion
Implantation of the device should be performed as per the manufacturer's IFU. Procedural details will be captured as appropriate on the procedural worksheets. Any Adverse Events or Device Deficiencies observed shall also be recorded. The following tests and examinations must be performed immediately after lead insertion: * Physical examination and vital signs (includes Pulse, Blood Pressure); * Laboratory testing per site standard practice; * ECG; * TTE; * Adverse event and device deficiencies assessment.
lead removal
Removal of the device should be performed as per the manufacturer's IFU. Procedural details will be captured as appropriate on the procedural worksheets. Any Adverse Events or Device Deficiencies observed shall also be recorded. The following tests and examinations must be performed immediately after lead removal: * Physical examination and vital signs (includes Pulse, Blood Pressure); * Laboratory testing per site standard practice; * ECG; * TTE; * Adverse event and device deficiencies assessment
Locations (3)
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, Bari, Italy
Ospedale del Cuore 'G. Pasquinucci' Fondazione Toscana 'Gabriele Monasterio'
Massa, Massa-Carrara, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, Italy