Status:
UNKNOWN
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
Lead Sponsor:
Medtronic BRC
Conditions:
Bradycardia; Sick Sinus Syndrome, AV Block
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
Detailed Description
Electrical stimulation in the apex of the right ventricle ( ventricular pacing) usually improves the heart function of patients with a pacemaker and can even be life-saving. However, evidence is accum...
Eligibility Criteria
Inclusion
- Patients shall be willing to sign the Patient Informed Consent for this study
- Patients shall have at least one of the following indications for a pacemaker: - Sick Sinus Syndrome with normal QRS complexes
- First degree AV block with a PR interval \<\_220 ms for patients \<\_ 70 years of age, or \<\_ 260 for patients over 70 years
- Second-degree AV block, mobitz I (wenckebach) or mobitz II
- Patients shall be available for follow-up for the duration of their participation.
Exclusion
- Patients involved in another investigation study conducted in parallel to this study
- Patients younger than 18 years of age and/or patients that do NOT meet other local requirements for participation
- Pregnant patients
- Patients with lead integrity problems (and the lead is not being replaced)
- Patients with persistant AF
- Patients with a complete AV block
- Patients with NYHA (New York Heart Association0 class III and IV
- Patients who underwent thoracic surgery in the last three months or are expected to have in the near future
- Patients with a 2:1 block
- Patients with a life expectancy less than half a year
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00156741
Start Date
April 1 2004
End Date
April 1 2006
Last Update
August 2 2011
Active Locations (30)
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1
A.ö. Krankenhaus der Elisabethinen Linz
Linz, Austria, 4010
2
Fakultni nemocnice u svate Anny v Berne
Brno, Czechia, 656 91
3
Fakulti Nemocnice, University Hospital of Brno-Bohunice
Brno- Bohunice, Czechia, 639 00
4
University Hospital with Polyclinics Ostrava
Ostrava, Czechia, 708 50