Phase 4
N=102
Electrophysiologically Guided PAcing Site Selection Study
Sinus Arrhythmia · Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00239226 ↗Enrolled (actual)
102
Serious AEs
3.1%
Results posted
Nov 2013
Primary outcome: Primary: Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group — 2; 2; 9; 2 Number of patients with persistent AF — p=0.047
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IAS pacing - study group (Procedure); IAS pacing control group (Procedure); Pacing RAA study group (Procedure); Pacing RAA control group (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic BRC
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group |
2; 2; 9; 2 | 0.047 sig |
| SECONDARY Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups |
— | — |
| SECONDARY Number of Patients With Permanent Atrial Fibrillation (AF) |
— | — |
| SECONDARY Symptom Scale Questionnaire: Comparison Between All Groups |
— | — |
| SECONDARY Number of Cardioversion: Comparison Between All Groups |
— | — |
| SECONDARY Heart Failure: Comparison Between All Groups |
— | — |
| SECONDARY Time to First Persistent Episode of Atrial Fibrillation (AF) |
— | — |
| SECONDARY Number of Episodes/Day |
— | — |
| SECONDARY AF Burden |
— | — |
| SECONDARY Ventricular Pacing Percentage |
— | — |
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).
Eligibility Criteria
Inclusion Criteria
- Symptomatic sinus node dysfunction
- More than 18 years old
- Signed informed consent
Exclusion Criteria
- Less than 18 years old
- Pregnancy
- Anamnestic transient ischemic attack (TIA) or stroke
- Neoplastic or any other severe disease reducing life expectancy
- Heart surgery in the last 3 months
- Left atrial diameter > 55mm, determined in the parasternal long-axis view (during either sinus rhythm or atrial fibrillation)
- Participation in other studies
Data sourced from ClinicalTrials.gov (NCT00239226). 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.