Status:
TERMINATED
EnTRINSIC - EnPulse Trial on Search AV+ Influence
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Arrhythmia, Sinus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even m...
Eligibility Criteria
Inclusion
- Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms
- Patients treated with a Medtronic pacemaker with Search AV+ algorithm
Exclusion
- Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction
- New York Heart Association (NYHA) III/IV
- Instable angina pectoris
- Heart valve vitium
- Persistent AV-block II and III
- Early diastolic mitral regurgitation
- Implantable cardioverter defibrillator
- Participation in other clinical studies
- Pregnancy or unreliable birth control
- AV-block under strain
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00157794
Start Date
February 1 2004
End Date
November 1 2007
Last Update
July 3 2025
Active Locations (14)
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1
Klinikum Großhadern Herzchirurgische Klinik und Poliklinik
Munich, Bavaria, Germany, 81377
2
Internistische Praxis Dr. Med. Schade
Berlin, Germany, 13187
3
St. Josefs Hospital
Bochum, Germany, 44791
4
Praxis Dr. Med. Markert
Gaggenau, Germany, 76571