Mintek Pacemaker LV-T Manuale Utente
Stratos LV/LV-T Technical Manual 39
The gender distribution in this clinical investigation was
consistent within the study groups and included a representative
proportion of enrolled female participants (57.2% versus 42.7%
male). There were no significant differences in the primary
safety or effectiveness endpoints between the male and female
population.
consistent within the study groups and included a representative
proportion of enrolled female participants (57.2% versus 42.7%
male). There were no significant differences in the primary
safety or effectiveness endpoints between the male and female
population.
1.7.2 Stratos LV Clinical Study – OVID study
The OVID clinical study collected significant safety data
supporting the Stratos LV/LV-T CRT-P system.
supporting the Stratos LV/LV-T CRT-P system.
Study Design
BIOTRONIK conducted the Corox Over-the-Wire Lead
Evaluation (OVID) prospective registry outside the United States
(OUS) of the Corox OTW Steroid LV lead in a multi-center trial
with legally marketed CRT-D and CRT-P pulse generators that
provide biventricular pacing therapy. Data from this registry is
presented in the following sections to support the safety of the
Stratos LV CRT-P.
Evaluation (OVID) prospective registry outside the United States
(OUS) of the Corox OTW Steroid LV lead in a multi-center trial
with legally marketed CRT-D and CRT-P pulse generators that
provide biventricular pacing therapy. Data from this registry is
presented in the following sections to support the safety of the
Stratos LV CRT-P.
The multi-center investigation was designed to validate the
safety of the Corox OTW Steroid LV lead through a comparison
of successfully implanted LV leads against a pre-defined
success rate threshold, when no anatomical restrictions prevent
access to the coronary sinus. The evaluation of safety is based
on the analysis of the incidence of adverse events, defined as
any complications or observations judged by the investigator to
be in probable relationship with Corox OTW Steroid LV lead
system. Additionally, the effectiveness of the leads was
evaluated using lead parameter data, including sensing
amplitudes, pacing thresholds, and impedance values.
safety of the Corox OTW Steroid LV lead through a comparison
of successfully implanted LV leads against a pre-defined
success rate threshold, when no anatomical restrictions prevent
access to the coronary sinus. The evaluation of safety is based
on the analysis of the incidence of adverse events, defined as
any complications or observations judged by the investigator to
be in probable relationship with Corox OTW Steroid LV lead
system. Additionally, the effectiveness of the leads was
evaluated using lead parameter data, including sensing
amplitudes, pacing thresholds, and impedance values.
In the OVID study, enrolled patients could be implanted with any
legally marketed CRT-P or CRT-D device. There were 121
patients enrolled in the OVID clinical study, and 89 patients were
implanted with a Stratos LV device.
legally marketed CRT-P or CRT-D device. There were 121
patients enrolled in the OVID clinical study, and 89 patients were
implanted with a Stratos LV device.