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

U.S., Sept. 16 -- ClinicalTrials.gov registry received information related to the study (NCT07820072) titled 'A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the SPIKE FLOW Endocardial Lead' on Sept. 09.

Brief 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-cente...