CTRI/2011/04/001658
Completed
Phase 4
Clinical Outcome of Pacemaker paTIents according to pacing Modality and primary INDications - OPTI-MIND
Guidant Europe a Boston Scientific Company Europe0 sites1,730 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Bradyarrhythmia
- Sponsor
- Guidant Europe a Boston Scientific Company Europe
- Enrollment
- 1730
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 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.
- •2\. 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;
- •3\. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion Criteria
- •1\. Unable to be followed up by the participating centres for a period of two years;
- •2\. Current device implanted for more than 15 days;
- •3\. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physicians discretion);
- •4\. 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.
Outcomes
Primary Outcomes
Not specified
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