SPIKE FLOW Endocardial Lead Safety and Performance Study
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- Who runs it
- FIAB SpA
- Trial code
- NCT07820072
- Record updated
- 12 November 2026
- Original description
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead.Read full original descriptionShow less
A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the SPIKE FLOW Endocardial Lead
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.
Inclusion: 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: Subject had a stroke within 6 months prior to enrollment; Subject has a co-existing temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator; 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 has an active systemic infection or local infection at or around the insertion site; Subject has renal insufficiency with creatinine >2 mg/dl; Subject in cardiogenic shock; Subject is currently in atrial fibrillation; Subject is pregnant or breastfeeding; 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 is involved in another clinical study that could influence the safety or outcome measures of this study.