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RECRUITING
NCT07820072
NA

SPIKE FLOW Endocardial Lead Safety and Performance Study

Sponsor: FIAB SpA

View on ClinicalTrials.gov

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 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.

Official title: A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the SPIKE FLOW Endocardial Lead

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

2026-10-20

Healthy Volunteers

No

Interventions

PROCEDURE

Lead insertion

Implantation of the device should be performed as per the manufacturer's Instructions for Use (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; * Electrocardiogram (ECG); * Transthoracic Echocardiogram (TTE); * Adverse events and device deficiencies assessment.

PROCEDURE

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