SPIKE FLOW Endocardial Lead Safety and Performance Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Study 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.

Eligibility

Primary outcome measure(s)

• Safety: Freedom from Severe ADEs — from insertion up to 30 days post-lead removal
• Performance: Mean Pacing Capture Threshold (>2V) — from insertion to Lead removal (Up to 7 days)

Trial sites (3)

Other trials for the same condition