Status:
COMPLETED
Adapta Pacing System Clinical Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Pacemaker
Bradycardia
Eligibility:
All Genders
Phase:
NA
Brief Summary
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too ...
Eligibility Criteria
Inclusion
- Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines
- Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form
Exclusion
- Subjects with a mechanical tricuspid valve
- Subjects with a life expectancy less than two years
- Subjects with a Class III indication for permanent pacing
- Subjects with lead integrity problems, unless leads are being replaced
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00307073
Start Date
May 1 2005
End Date
November 1 2005
Last Update
October 12 2006
Active Locations (7)
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1
Graz, Austria
2
Prague, Czechia
3
Bad Nauheim, Germany
4
Hamburg, Germany