N/A
Completed N=211
REASSURE AV Registry
Sudden Cardiac Death · Bradycardia
Source: ClinicalTrials.gov NCT01074034 ↗
Enrolled (actual)
211
Serious AEs
24.6%
Results posted
Jun 2017
Primary outcomePrimary: Inappropriate Shock Free Rate — 97.2 % of shock free rates
Summary
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inappropriate Shock Free Rate |
97.2 | — |
| SECONDARY Conversion Success Rate up to Three Months Post-implant |
90.9 | — |
Eligibility Criteria
Inclusion Criteria
- The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol
- Patient is implanted with an investigational B301 device as part of the REASSURE AV study
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01074034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.