At a glance
ClinicalIndex Comparison RecordN/ACompleted· 211 enrolled
Drug / intervention
AV Therapy Assessment-B301 investigational devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry
In Brief
A clinical study evaluating AV Therapy Assessment-B301 investigational device for Sudden Cardiac Death and Bradycardia. Completed, enrolled 211 participants across 36 sites.
Detailed Summary
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSudden Cardiac Death, Bradycardia
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedFeb 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedFeb 24, 2010
Enrollment StartApr 1, 2006
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.4 years ago
Interventions
AV Therapy Assessment-B301 investigational devicedevice
Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device