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SPIKE FLOW Endocardial Lead Safety and Performance Study

Sponsor: FIAB SpA • ClinicalTrials.gov ID: NCT07820072

Registry updated: 2026-10-20

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Description

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.

Interventions

Lead insertion (Procedure)
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.
lead removal (Procedure)
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

Eligibility criteria

Inclusion Criteria: * Subject undergoing a surgical or an interventional procedure, requiring temporary cardiac pacing per investigator's medical judgment or subjects with bradycardia who are under evaluation to determine if the cause is transient or permanent; * Subject is at least 18 years of age; * Subject provides written informed consent to the study. Exclusion Criteria: * Subject has a co-existing temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator; * Subject in cardiogenic shock; * Subject is currently in atrial fibrillation; * Subject is pregnant or breastfeeding; * Subject had a stroke within 6 months prior to enrollment; * Subject has renal insufficiency with creatinine \>2 mg/dl; * Subject with known bleeding diathesis; * Subject with a history of deep vein thrombosis or pulmonary embolism within 6 months; * Subject with known tricuspid valve disease that may impede catheter advancement to and withdrawal from the right ventricle; * Subject with known intracardiac thrombus or vegetation on echocardiography; * Subject with significant neck abnormalities such that placement of a right and/or left internal jugular vein line would be difficult; * Subject has an active systemic infection or local infection at or around the insertion site; * Subject is involved in another clinical study that could influence the safety or outcome measures of this study.

Conditions

Acute Myocardial Infarction (AMI) Asystole Bradycardia AV Block Ventricular Tachyarrhythmia

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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