Status:
COMPLETED
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Bradyarrhythmia
Eligibility:
All Genders
18+ years
Brief Summary
The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international e...
Detailed Description
The principal objective of the OPTI-MIND study is to collect data on two-year all-cause mortality in a general population implanted with a PM according to current clinical practice. Additionally, the ...
Eligibility Criteria
Inclusion
- Patients implanted with a current Boston Scientific pacemaker (all ALTRUA models) or any future commercially available Boston Scientific PM families according to international and local guidelines for pacemaker implantation;
- Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
- Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion
- Unable to be followed up by the participating centres for a period of two years;
- Current device implanted for more than 15 days;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol. Each instance should be brought to the attention of the sponsor to determine eligibility.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
1745 Patients enrolled
Trial Details
Trial ID
NCT00976482
Start Date
September 1 2009
End Date
September 1 2013
Last Update
February 1 2017
Active Locations (1)
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1
Katholisches Krankenhaus, St.Johannes Hospital
Hagen, Germany