Ventricular Fibrillation Clinical Trial
Official title:
RELIANCE 4-FRONTâ„¢ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONTâ„¢ Passive Fixation Defibrillation Leads.
The RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up
Study is a prospective, non-randomized, multi-center, single-group, post market clinical
study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT
passive fixation defibrillation leads.
A total of 167 patients (including 10 % attrition) are required to evaluate the Primary
Endpoint.
Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free
Rate (CFR) from Implant through 3 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will
count toward this endpoint.
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will
count toward this endpoint.
- Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
- Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant
- Sensed Amplitude at 3 Months Post-Implant
- Pacing Impedance at 3 Months Post-Implant All endpoints will be assessed for the
RELIANCE 4-FRONT passive fixation lead.
Clinic visits will occur at:
- Enrollment Visit (no later than 30 days prior to implant procedure)
- Implant Procedure (Day 0; all future follow ups based on this date)
- Pre-Discharge Clinic Visit (3 - 72 hours post-implant)
- One Month Clinic Visit (30±7 days)
- 3 Month Clinic Visit (91 ± 21 days)
- 6 Month Clinic Visit (180 ± 30 days)
- 12 Month Clinic Visit (365 ± 45 days)
- 18 Month Clinic Visit (545± 45 days)
- 24 Month Clinic Visit (730 ± 45 days) The study will be considered completed after all
subjects have completed the 24 Month follow-up and study completion is anticipated in
2015. Primary endpoint completion is anticipated after all subjects have completed the 3
Month follow-up visit. All study required visits will be completed during clinic visits.
Hypotheses testing in the RELIANCE 4-FRONT passive fixation PMCF Study will use standard
statistical methodology as specified more in detail in the protocol.
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