Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.

Official Title
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Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

Conditions
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Bradyarrhythmia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients implanted with any of BSC dual chamber PM devices equipped with RHYTMIQ with the algorithm programed to ON based on clinical indication at the time of discharge from the hospital Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Patients with 3rd degree AV block Patients with permanent AF Patients followed up remotely with remote patient management system. Patients who are unable to be followed up by the participating centers for a period of two years Patients who have a current device implanted for more than 15 days Women of childbearing potential who are pregnant, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RYTHMIQ study group<br> | |
| Historical control from OPTI-MIND<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature | Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature compared to data from a cohort of subjects implanted with BSC PM without RYTHMIQ pooled from OPTI-MIND study. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics. | A multivariate model will be used to find the independent association with the combined primary endpoint, RYTHMIQ algorithm and other patient characteristics. Variables of interests include (but are not limited to): primary pacing indication (SND vs AVB), degree of AVB, age, gender, underlying disease, use of Betablockers, history of atrial fibrillation, LVEF, NYHA class, RV lead position, type of sensors used. | 2 years |