At a glance
ClinicalIndex Comparison RecordN/ACompleted· 139 enrolled
Drug / intervention
RAAT +1 moredevice
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.
Ingenio Device Algorithm Study
In Brief
A clinical study evaluating RAAT and RYTHMIQ for Sinus Node Disease and 2 related conditions. Completed, enrolled 139 participants across 21 sites in 12 countries.
Detailed Summary
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinus Node Disease, AV Block, Heart Failure
CountriesAustria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Malaysia, Netherlands, Spain, Sweden, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartOct 2011
Primary CompletionJun 2012
Study CompletionApr 2013
TodayJul 2026
First PostedSep 27, 2011
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.8 years ago
Interventions
RAATdevice
For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)
RYTHMIQdevice
For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment