Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study

Brief Summary

Detailed Description

The primary safety endpoint is freedom from Adverse Device Effects, CTCAE Grade 3 or higher. The primary performance endpoint is percentage of Subjects with demonstrated pacing capture following lead fixation. Up to 30 subjects will be enrolled at up to three (3) investigation centers. Enrolled subjects will undergo insertion of a StealthTrac Lead within one calendar day of an eligible planned index procedure that requires a temporary pacing lead. Echocardiographic evaluations will be performed before and after StealthTrac Lead insertion, as well as after the index procedure, to assess for pericardial effusion. Post-operative fluoroscopic images are required in all subjects to document the final lead position. In subjects without an underlying ventricular escape rhythm, a concomitant, commercially available pacing lead is required. Lead measurements (Thresholds, Impedance, R-Waves) and an insertion procedure survey will be obtained. Subjects will be restricted to bed rest while the StealthTrac lead remains inserted. The StealthTrac Lead will be connected to a commercially available, constant-current temporary pacemaker programmed by the investigator to provide temporary pacing support. The StealthTrac Lead will remain inserted until the next calendar day, at a minimum, and will be removed once the clinical need for temporary pacing ends. The maximum duration of lead insertion is two (2) days following the lead insertion procedure. Follow up evaluations will be performed for as long as the StealthTrac Lead remains inserted. Subjects will also undergo a 30-day post-removal follow-up before completing participation. On the final follow-up, prior to StealthTrac Lead removal, Subjects may be tested in multiple postures. Subjects with pacing capture in the upright posture may have ECGs recorded during various isometrics or while walking with pacing from the StealthTrac Lead. Prior to removal, a final lead evaluation will be performed and fluoroscopy will be used to document the final lead position. Echocardiographic imaging will be obtained before and after the removal procedure to characterize any new or worsened pericardial effusions. A final post-removal follow-up will be performed in person or remotely to document any latent adverse events. The overall study is expected to last four (4) months, comprising two (2) months for enrollment and follow-up and two (2) months to monitor study data and prepare a final report.

Primary Outcomes