At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 102 enrolled
Drug / intervention
IAS pacing - study group +3 moreprocedure
Likely dose
Not stated in record
Key inclusion· 3
- ✓Symptomatic sinus node dysfunction
- ✓Age > 18 years
- ✓Signed informed consent
Key exclusion· 6
- ✕Pregnancy
- ✕History of transient ischemic attack (TIA) or stroke
- ✕Neoplastic or severe disease reducing life expectancy
- ✕Heart surgery within 3 months prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigational New Drug Application/ Investigational Device Exemption Information
In Brief
A Phase 4 clinical trial evaluating IAS pacing - study group, IAS pacing control group, and 2 other interventions for Sinus Arrhythmia and Atrial Fibrillation. Completed, enrolled 102 participants across 8 sites.
Detailed Summary
This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced with preventive algorithms at the interatrial septum (IAS) versus right atrial appendage (RAA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinus Arrhythmia, Atrial Fibrillation
CountriesItaly
CollaboratorsMedtronic
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2005
Enrollment StartNov 2005
Primary CompletionDec 2008
Study CompletionMar 2009
TodayJul 2026
First PostedOct 14, 2005
Enrollment StartNov 1, 2005
Primary CompletionDec 1, 2008
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.7 years ago
Interventions
IAS pacing - study groupprocedure
site of implant and permanent pacing
IAS pacing control groupprocedure
site of implant and permanent pacing
Pacing RAA study groupprocedure
site of implant and permanent pacing
Pacing RAA control groupprocedure
site of implant and permanent pacing