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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 environment.
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 study aims to stratify the outcome by both known patient-related risk factors and by physiologic pacing mode setting (a specifically defined PM programming). Stratification will be done for pre-specified classes of patients on the basis of their primary rhythm disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacemaker | Patients currently implanted with permanent Pacemaker according to guidelines |
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| Measure | Description | Time Frame |
|---|---|---|
| Two-year All-cause Mortality | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patient implanted with permanent pacemaker accroding to guidelines.
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Biffi, MD | Az. Osp. S. orsola - Malpighi, Bologna, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholisches Krankenhaus, St.Johannes Hospital | Hagen | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pacemaker | Patients currently implanted with permanent Pacemaker according to guidelines |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
among the 1745 initial patients 5 were excluded for inclusion criteria violations (deviations from correct signature of informed consent)
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| ID | Title | Description |
|---|---|---|
| BG000 | Pacemaker | Patients currently implanted with permanent Pacemaker according to guidelines |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Two-year All-cause Mortality | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pacemaker | implanted Patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| disease progression leading to death | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr Mauro Biffi | ospedale S Orsola- Malpighi, Bologna, Italy | +393337661449 | mauro.biffi@aosp.bo.it |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Protocol Violation |
|
| years |
|
| Gender | Count of Participants | Participants |
|
| Primary Indication for Permanent Pacing | Number | participants |
|
|
| 611 |
| 1,740 |
| 206 |
| 1,740 |
| leading to invasive interventions | Cardiac disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |