Status:
COMPLETED
Electrophysiologically Guided PAcing Site Selection Study
Lead Sponsor:
Medtronic BRC
Collaborating Sponsors:
Medtronic
Conditions:
Sinus Arrhythmia
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 prevent...
Detailed Description
The EPASS is a multicenter, prospective, randomized, and controlled study. Prior to entering the study, the patient should be informed and provide a written consent. In addition, the patient should m...
Eligibility Criteria
Inclusion
- Symptomatic sinus node dysfunction
- More than 18 years old
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00239226
Start Date
November 1 2005
End Date
March 1 2009
Last Update
November 25 2013
Active Locations (8)
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1
Azienda Ospedaliera di Desenzano del Garda
Desenzano, BS, Italy
2
Divisione di Cardiologia
Como, CO, Italy, 22100
3
Divisione di Cardiologia - CRN
Pisa, PI, Italy, 56127
4
Divisione di Cardiologia - Ospedale Cisanello
Pisa, PI, Italy, 56127