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

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.

Eligibility

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-exist temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator;
* Subject on 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 embolization within 6 months;
* Subject with known tricuspid valve disease that may impede catheter advance to and withdrawn from right ventricle;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.

Conditions2

Browse More Trials