Status:
UNKNOWN
Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
Lead Sponsor:
Vitatron France
Conditions:
Sick Sinus Syndrome
Brady-Tachy Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF). T...
Detailed Description
Due to anti-arrhythmic pharmacological drugs failure to suppress atrial fibrillation (AF), interest towards preventive pacing treatments is increasing. The importance of this option in the panoply of ...
Eligibility Criteria
Inclusion
- Patient with documented atrial fibrillation: at least one episode of paroxysmal AF documented 6 months prior to inclusion, lasting more than one minute
- Patient with a brady-tachy syndrome or a sick sinus syndrome, with a permanent pacing indication
- Atrial lead with a tip-to-ring interval equal to or less than 12 mm
- Patient who agrees with and has signed the informed consent
Exclusion
- Permanent AF
- AF related to a reversible cause
- One electrical cardioversion 6 months prior to inclusion
- Unstable angina
- Myocardial infarction (MI) less than 3 months
- Planned cardiac surgery or performed in the last 3 months
- Congestive heart failure, New York Heart Association (NYHA) class IV
- Life expectancy less than 18 months
- Patient participating in other studies
- Patient not able to follow the FU calendar
- Less than 18 years of age
- Pregnancy
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00224341
Start Date
November 1 2003
End Date
November 1 2006
Last Update
October 18 2006
Active Locations (37)
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1
CHG
Abbeville, France, 80100
2
Hopital Privé
Antony, France, 92160
3
CH
Auxerre, France, 89011
4
CH
Avignon, France, 84902